User login
Suicide rates up significantly among adolescents, young adults
Suicide rates in young people aged 10-24 years increased significantly in 42 states from 2007-2009 to 2016-2018, according to a recent analysis from the National Center for Health Statistics.
Nationally, the suicide rate jumped 47%, based on the averages for the two 3-year periods, rising from 7.0 per 100,000 persons aged 10-24 years to 10.3 per 100,000. For all ages, the corresponding increase was 47%, Sally C. Curtin, MA, of the NCHS, said in a National Vital Statistics Report.
There was no state with a decrease in suicide rates for adolescents and young adults, as the other eight all had nonsignificant increases, the smallest being 14% in South Dakota. Three-year averages were used to increase statistical power for states with relatively small numbers of deaths but were still not enough to show significance for some large increases, such as the 48% rise in Delaware, Ms. Curtin noted.
In 2016-2018, Alaska’s suicide rate of 31.8 per 100,000 persons aged 10-24 years was the highest in the country, followed by South Dakota (23.6), Montana (23.2), and Wyoming (20.5). New Jersey had the lowest rate at 5.7 per 100,000, with New York and Rhode Island both slightly higher at 5.9 and Connecticut at 6.3, based on data from the National Vital Statistics System.
Even the low numbers, however, hide some large changes, as New Jersey (up by 39%) and New York (up by 44%) were among the 42 states with statistically significant increases, which ranged from 21.7% in Maryland to 110% in New Hampshire, Ms. Curtin said in the report. The increases seen in this analysis contrast with data from the preceding time period, as “the suicide rate among persons aged 10-24 was statistically stable from 2000 to 2007.”
SOURCE: Curtin SC. National Vital Statistics Reports. 2020;69(11)1-9.
Suicide rates in young people aged 10-24 years increased significantly in 42 states from 2007-2009 to 2016-2018, according to a recent analysis from the National Center for Health Statistics.
Nationally, the suicide rate jumped 47%, based on the averages for the two 3-year periods, rising from 7.0 per 100,000 persons aged 10-24 years to 10.3 per 100,000. For all ages, the corresponding increase was 47%, Sally C. Curtin, MA, of the NCHS, said in a National Vital Statistics Report.
There was no state with a decrease in suicide rates for adolescents and young adults, as the other eight all had nonsignificant increases, the smallest being 14% in South Dakota. Three-year averages were used to increase statistical power for states with relatively small numbers of deaths but were still not enough to show significance for some large increases, such as the 48% rise in Delaware, Ms. Curtin noted.
In 2016-2018, Alaska’s suicide rate of 31.8 per 100,000 persons aged 10-24 years was the highest in the country, followed by South Dakota (23.6), Montana (23.2), and Wyoming (20.5). New Jersey had the lowest rate at 5.7 per 100,000, with New York and Rhode Island both slightly higher at 5.9 and Connecticut at 6.3, based on data from the National Vital Statistics System.
Even the low numbers, however, hide some large changes, as New Jersey (up by 39%) and New York (up by 44%) were among the 42 states with statistically significant increases, which ranged from 21.7% in Maryland to 110% in New Hampshire, Ms. Curtin said in the report. The increases seen in this analysis contrast with data from the preceding time period, as “the suicide rate among persons aged 10-24 was statistically stable from 2000 to 2007.”
SOURCE: Curtin SC. National Vital Statistics Reports. 2020;69(11)1-9.
Suicide rates in young people aged 10-24 years increased significantly in 42 states from 2007-2009 to 2016-2018, according to a recent analysis from the National Center for Health Statistics.
Nationally, the suicide rate jumped 47%, based on the averages for the two 3-year periods, rising from 7.0 per 100,000 persons aged 10-24 years to 10.3 per 100,000. For all ages, the corresponding increase was 47%, Sally C. Curtin, MA, of the NCHS, said in a National Vital Statistics Report.
There was no state with a decrease in suicide rates for adolescents and young adults, as the other eight all had nonsignificant increases, the smallest being 14% in South Dakota. Three-year averages were used to increase statistical power for states with relatively small numbers of deaths but were still not enough to show significance for some large increases, such as the 48% rise in Delaware, Ms. Curtin noted.
In 2016-2018, Alaska’s suicide rate of 31.8 per 100,000 persons aged 10-24 years was the highest in the country, followed by South Dakota (23.6), Montana (23.2), and Wyoming (20.5). New Jersey had the lowest rate at 5.7 per 100,000, with New York and Rhode Island both slightly higher at 5.9 and Connecticut at 6.3, based on data from the National Vital Statistics System.
Even the low numbers, however, hide some large changes, as New Jersey (up by 39%) and New York (up by 44%) were among the 42 states with statistically significant increases, which ranged from 21.7% in Maryland to 110% in New Hampshire, Ms. Curtin said in the report. The increases seen in this analysis contrast with data from the preceding time period, as “the suicide rate among persons aged 10-24 was statistically stable from 2000 to 2007.”
SOURCE: Curtin SC. National Vital Statistics Reports. 2020;69(11)1-9.
Disparities seen in COVID-19–related avoidance of care
In the early weeks and months of the COVID-19 pandemic, many people were trying to avoid the coronavirus by staying away from emergency rooms and medical offices. But how many people is “many”?
Turns out almost 41% of Americans delayed or avoided some form of medical care because of concerns about COVID-19, according to the results of a survey conducted June 24-30 by commercial survey company Qualtrics.
More specifically, the avoidance looks like this: 31.5% of the 4,975 adult respondents had avoided routine care and 12.0% had avoided urgent or emergency care, Mark E. Czeisler and associates said in the Morbidity and Mortality Weekly Report. The two categories were not mutually exclusive since respondents could select both routine care and urgent/emergency care.
There were, however, a number of significant disparities hidden among those numbers for the overall population. Blacks and Hispanics, with respective prevalences of 23.3% and 24.6%, were significantly more likely to delay or avoid urgent/emergency care than were Whites (6.7%), said Mr. Czeisler, a graduate student at Monash University, Melbourne, and associates.
Those differences “are especially concerning given increased COVID-19–associated mortality among Black adults and Hispanic adults,” they noted, adding that “age-adjusted COVID-19 hospitalization rates are approximately five times higher among Black persons and four times higher among Hispanic persons than” among Whites.
Other significant disparities in urgent/emergency care avoidance included the following:
- Unpaid caregivers for adults (29.8%) vs. noncaregivers (5.4%).
- Adults with two or more underlying conditions (22.7%) vs. those without such conditions (8.2%).
- Those with a disability (22.8%) vs. those without (8.9%).
- Those with health insurance (12.4%) vs. those without (7.8%).
The highest prevalence for all types of COVID-19–related delay and avoidance came from the adult caregivers (64.3%), followed by those with a disability (60.3%) and adults aged 18-24 years (57.2%). The lowest prevalence numbers were for adults with health insurance (24.8%) and those who were not caregivers for adults (32.2%), Mr. Czeisler and associates reported.
These reports of delayed and avoided care “might reflect adherence to community mitigation efforts such as stay-at-home orders, temporary closures of health facilities, or additional factors. However, if routine care avoidance were to be sustained, adults could miss opportunities for management of chronic conditions, receipt of routine vaccinations, or early detection of new conditions, which might worsen outcomes,” they wrote.
SOURCE: Czeisler ME et al. MMWR. 2020 Sep 11;69(36):1250-7.
In the early weeks and months of the COVID-19 pandemic, many people were trying to avoid the coronavirus by staying away from emergency rooms and medical offices. But how many people is “many”?
Turns out almost 41% of Americans delayed or avoided some form of medical care because of concerns about COVID-19, according to the results of a survey conducted June 24-30 by commercial survey company Qualtrics.
More specifically, the avoidance looks like this: 31.5% of the 4,975 adult respondents had avoided routine care and 12.0% had avoided urgent or emergency care, Mark E. Czeisler and associates said in the Morbidity and Mortality Weekly Report. The two categories were not mutually exclusive since respondents could select both routine care and urgent/emergency care.
There were, however, a number of significant disparities hidden among those numbers for the overall population. Blacks and Hispanics, with respective prevalences of 23.3% and 24.6%, were significantly more likely to delay or avoid urgent/emergency care than were Whites (6.7%), said Mr. Czeisler, a graduate student at Monash University, Melbourne, and associates.
Those differences “are especially concerning given increased COVID-19–associated mortality among Black adults and Hispanic adults,” they noted, adding that “age-adjusted COVID-19 hospitalization rates are approximately five times higher among Black persons and four times higher among Hispanic persons than” among Whites.
Other significant disparities in urgent/emergency care avoidance included the following:
- Unpaid caregivers for adults (29.8%) vs. noncaregivers (5.4%).
- Adults with two or more underlying conditions (22.7%) vs. those without such conditions (8.2%).
- Those with a disability (22.8%) vs. those without (8.9%).
- Those with health insurance (12.4%) vs. those without (7.8%).
The highest prevalence for all types of COVID-19–related delay and avoidance came from the adult caregivers (64.3%), followed by those with a disability (60.3%) and adults aged 18-24 years (57.2%). The lowest prevalence numbers were for adults with health insurance (24.8%) and those who were not caregivers for adults (32.2%), Mr. Czeisler and associates reported.
These reports of delayed and avoided care “might reflect adherence to community mitigation efforts such as stay-at-home orders, temporary closures of health facilities, or additional factors. However, if routine care avoidance were to be sustained, adults could miss opportunities for management of chronic conditions, receipt of routine vaccinations, or early detection of new conditions, which might worsen outcomes,” they wrote.
SOURCE: Czeisler ME et al. MMWR. 2020 Sep 11;69(36):1250-7.
In the early weeks and months of the COVID-19 pandemic, many people were trying to avoid the coronavirus by staying away from emergency rooms and medical offices. But how many people is “many”?
Turns out almost 41% of Americans delayed or avoided some form of medical care because of concerns about COVID-19, according to the results of a survey conducted June 24-30 by commercial survey company Qualtrics.
More specifically, the avoidance looks like this: 31.5% of the 4,975 adult respondents had avoided routine care and 12.0% had avoided urgent or emergency care, Mark E. Czeisler and associates said in the Morbidity and Mortality Weekly Report. The two categories were not mutually exclusive since respondents could select both routine care and urgent/emergency care.
There were, however, a number of significant disparities hidden among those numbers for the overall population. Blacks and Hispanics, with respective prevalences of 23.3% and 24.6%, were significantly more likely to delay or avoid urgent/emergency care than were Whites (6.7%), said Mr. Czeisler, a graduate student at Monash University, Melbourne, and associates.
Those differences “are especially concerning given increased COVID-19–associated mortality among Black adults and Hispanic adults,” they noted, adding that “age-adjusted COVID-19 hospitalization rates are approximately five times higher among Black persons and four times higher among Hispanic persons than” among Whites.
Other significant disparities in urgent/emergency care avoidance included the following:
- Unpaid caregivers for adults (29.8%) vs. noncaregivers (5.4%).
- Adults with two or more underlying conditions (22.7%) vs. those without such conditions (8.2%).
- Those with a disability (22.8%) vs. those without (8.9%).
- Those with health insurance (12.4%) vs. those without (7.8%).
The highest prevalence for all types of COVID-19–related delay and avoidance came from the adult caregivers (64.3%), followed by those with a disability (60.3%) and adults aged 18-24 years (57.2%). The lowest prevalence numbers were for adults with health insurance (24.8%) and those who were not caregivers for adults (32.2%), Mr. Czeisler and associates reported.
These reports of delayed and avoided care “might reflect adherence to community mitigation efforts such as stay-at-home orders, temporary closures of health facilities, or additional factors. However, if routine care avoidance were to be sustained, adults could miss opportunities for management of chronic conditions, receipt of routine vaccinations, or early detection of new conditions, which might worsen outcomes,” they wrote.
SOURCE: Czeisler ME et al. MMWR. 2020 Sep 11;69(36):1250-7.
One in seven high schoolers is misusing opioids
according to an analysis from the Centers for Disease Control and Prevention.
That type of opioid use/misuse, reported by 14.3% of respondents to the 2019 Youth Risk Behavior Survey, was more common among females (16.1%) than males (12.4%) and even more prevalent among nonheterosexuals and those who are unsure about their sexual identity, Christopher M. Jones, PharmD, DrPH, and associates at the CDC said in the Morbidity and Mortality Weekly Report.
The YRBS data show that 18.5% of gay or lesbian students had, at some point in their lives, used a prescription opioid differently than a physician had told them to or taken one without a prescription. That figure was slightly higher (19.1%) for those unsure of their sexual identity, considerably higher (25.4%) for bisexuals, and lower for heterosexuals (12.7%), they reported.
The pattern for current use/misuse of opioids, defined as use one or more times in the 30 days before the survey, was similar to ever use but somewhat less pronounced in 2019. Prevalence was 7.2% for all students in grades 9-12, 8.3% for females, and 6.1% for males. By sexual identity, prevalence was 6.4% for heterosexuals, 7.6% for gays or lesbians, 11.5% for those unsure about their sexual identity, and 13.1% for bisexuals, based on the YRBS data.
This increased misuse of opioids among sexual minority youths, “even after controlling for other demographic and substance use characteristics ... emphasizes the importance of identifying tailored prevention strategies to address disparities among this vulnerable population,” the CDC researchers wrote.
SOURCE: Jones CM et al. MMWR Suppl. 2020 Aug 21;69(1):38-46.
according to an analysis from the Centers for Disease Control and Prevention.
That type of opioid use/misuse, reported by 14.3% of respondents to the 2019 Youth Risk Behavior Survey, was more common among females (16.1%) than males (12.4%) and even more prevalent among nonheterosexuals and those who are unsure about their sexual identity, Christopher M. Jones, PharmD, DrPH, and associates at the CDC said in the Morbidity and Mortality Weekly Report.
The YRBS data show that 18.5% of gay or lesbian students had, at some point in their lives, used a prescription opioid differently than a physician had told them to or taken one without a prescription. That figure was slightly higher (19.1%) for those unsure of their sexual identity, considerably higher (25.4%) for bisexuals, and lower for heterosexuals (12.7%), they reported.
The pattern for current use/misuse of opioids, defined as use one or more times in the 30 days before the survey, was similar to ever use but somewhat less pronounced in 2019. Prevalence was 7.2% for all students in grades 9-12, 8.3% for females, and 6.1% for males. By sexual identity, prevalence was 6.4% for heterosexuals, 7.6% for gays or lesbians, 11.5% for those unsure about their sexual identity, and 13.1% for bisexuals, based on the YRBS data.
This increased misuse of opioids among sexual minority youths, “even after controlling for other demographic and substance use characteristics ... emphasizes the importance of identifying tailored prevention strategies to address disparities among this vulnerable population,” the CDC researchers wrote.
SOURCE: Jones CM et al. MMWR Suppl. 2020 Aug 21;69(1):38-46.
according to an analysis from the Centers for Disease Control and Prevention.
That type of opioid use/misuse, reported by 14.3% of respondents to the 2019 Youth Risk Behavior Survey, was more common among females (16.1%) than males (12.4%) and even more prevalent among nonheterosexuals and those who are unsure about their sexual identity, Christopher M. Jones, PharmD, DrPH, and associates at the CDC said in the Morbidity and Mortality Weekly Report.
The YRBS data show that 18.5% of gay or lesbian students had, at some point in their lives, used a prescription opioid differently than a physician had told them to or taken one without a prescription. That figure was slightly higher (19.1%) for those unsure of their sexual identity, considerably higher (25.4%) for bisexuals, and lower for heterosexuals (12.7%), they reported.
The pattern for current use/misuse of opioids, defined as use one or more times in the 30 days before the survey, was similar to ever use but somewhat less pronounced in 2019. Prevalence was 7.2% for all students in grades 9-12, 8.3% for females, and 6.1% for males. By sexual identity, prevalence was 6.4% for heterosexuals, 7.6% for gays or lesbians, 11.5% for those unsure about their sexual identity, and 13.1% for bisexuals, based on the YRBS data.
This increased misuse of opioids among sexual minority youths, “even after controlling for other demographic and substance use characteristics ... emphasizes the importance of identifying tailored prevention strategies to address disparities among this vulnerable population,” the CDC researchers wrote.
SOURCE: Jones CM et al. MMWR Suppl. 2020 Aug 21;69(1):38-46.
FROM MMWR
Atezolizumab TNBC indication ‘in jeopardy’ because of phase 3 results
The FDA said the phase 3 IMpassion131 trial showed that atezolizumab plus paclitaxel did not significantly reduce the risk of cancer progression and death, when compared with paclitaxel plus placebo, in programmed death-ligand 1 (PD-L1)–positive patients.
“Additionally, interim overall survival results favored paclitaxel plus placebo over paclitaxel plus atezolizumab in both the PD-L1-positive population and total population,” the FDA noted.
As a result, “health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice,” the FDA advised.
Atezolizumab is approved for use in combination with protein-bound paclitaxel, also known as nanoparticle albumin–bound paclitaxel (nab-paclitaxel), to treat patients with unresectable, locally advanced, or metastatic TNBC whose tumors express PD-L1, as detected by an FDA-approved test. The combination was granted accelerated approval for this indication last year.
Atezolizumab plus nab-paclitaxel is the combination most often used in PD-L1-positive TNBC, as opposed to atezolizumab and unbound paclitaxel, said Melinda L. Telli, MD, an associate professor of medicine and director of the Stanford Cancer Institute Breast Cancer Program at Stanford (Calif.) University.
However, as the FDA noted, “continued approval of atezolizumab in combination with [nab-paclitaxel] may be contingent on proven benefit of the treatment in additional trials.”
Dr. Telli explained that atezolizumab was granted accelerated approval for the treatment of PD-L1-positive TNBC based on results of the phase 3 IMpassion130 trial, which compared nab-paclitaxel plus atezolizumab with nab-paclitaxel plus placebo.
“Additional data from IMpassion131 was hoped to be used to support the conversion of the accelerated approval to a full approval. Since IMpassion131 was negative, it unfortunately places the status of atezolizumab in [TNBC] in jeopardy as the benefits were not corroborated. The FDA may move to revoke the approval of atezolizumab for [TNBC],” Dr. Telli said.
In its alert, the FDA stated that it “will review the findings of IMpassion131 and will communicate new information regarding the IMpassion131 results and any potential changes to prescribing information.”
“We need to wait for full presentation and publication of the study results, but, in my assessment, the negative results in IMpassion131 are most likely due to differences in patient selection [from IMpassion130],” Dr. Telli said.
Results from IMpassion131 are scheduled to be presented at the ESMO Virtual Congress 2020.
The IMpassion trials were funded by Roche, maker of atezolizumab. Dr. Telli disclosed relationships with AbbVie, AstraZeneca, Merck, PharmaMar, Pfizer, and Tesaro.
The FDA said the phase 3 IMpassion131 trial showed that atezolizumab plus paclitaxel did not significantly reduce the risk of cancer progression and death, when compared with paclitaxel plus placebo, in programmed death-ligand 1 (PD-L1)–positive patients.
“Additionally, interim overall survival results favored paclitaxel plus placebo over paclitaxel plus atezolizumab in both the PD-L1-positive population and total population,” the FDA noted.
As a result, “health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice,” the FDA advised.
Atezolizumab is approved for use in combination with protein-bound paclitaxel, also known as nanoparticle albumin–bound paclitaxel (nab-paclitaxel), to treat patients with unresectable, locally advanced, or metastatic TNBC whose tumors express PD-L1, as detected by an FDA-approved test. The combination was granted accelerated approval for this indication last year.
Atezolizumab plus nab-paclitaxel is the combination most often used in PD-L1-positive TNBC, as opposed to atezolizumab and unbound paclitaxel, said Melinda L. Telli, MD, an associate professor of medicine and director of the Stanford Cancer Institute Breast Cancer Program at Stanford (Calif.) University.
However, as the FDA noted, “continued approval of atezolizumab in combination with [nab-paclitaxel] may be contingent on proven benefit of the treatment in additional trials.”
Dr. Telli explained that atezolizumab was granted accelerated approval for the treatment of PD-L1-positive TNBC based on results of the phase 3 IMpassion130 trial, which compared nab-paclitaxel plus atezolizumab with nab-paclitaxel plus placebo.
“Additional data from IMpassion131 was hoped to be used to support the conversion of the accelerated approval to a full approval. Since IMpassion131 was negative, it unfortunately places the status of atezolizumab in [TNBC] in jeopardy as the benefits were not corroborated. The FDA may move to revoke the approval of atezolizumab for [TNBC],” Dr. Telli said.
In its alert, the FDA stated that it “will review the findings of IMpassion131 and will communicate new information regarding the IMpassion131 results and any potential changes to prescribing information.”
“We need to wait for full presentation and publication of the study results, but, in my assessment, the negative results in IMpassion131 are most likely due to differences in patient selection [from IMpassion130],” Dr. Telli said.
Results from IMpassion131 are scheduled to be presented at the ESMO Virtual Congress 2020.
The IMpassion trials were funded by Roche, maker of atezolizumab. Dr. Telli disclosed relationships with AbbVie, AstraZeneca, Merck, PharmaMar, Pfizer, and Tesaro.
The FDA said the phase 3 IMpassion131 trial showed that atezolizumab plus paclitaxel did not significantly reduce the risk of cancer progression and death, when compared with paclitaxel plus placebo, in programmed death-ligand 1 (PD-L1)–positive patients.
“Additionally, interim overall survival results favored paclitaxel plus placebo over paclitaxel plus atezolizumab in both the PD-L1-positive population and total population,” the FDA noted.
As a result, “health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice,” the FDA advised.
Atezolizumab is approved for use in combination with protein-bound paclitaxel, also known as nanoparticle albumin–bound paclitaxel (nab-paclitaxel), to treat patients with unresectable, locally advanced, or metastatic TNBC whose tumors express PD-L1, as detected by an FDA-approved test. The combination was granted accelerated approval for this indication last year.
Atezolizumab plus nab-paclitaxel is the combination most often used in PD-L1-positive TNBC, as opposed to atezolizumab and unbound paclitaxel, said Melinda L. Telli, MD, an associate professor of medicine and director of the Stanford Cancer Institute Breast Cancer Program at Stanford (Calif.) University.
However, as the FDA noted, “continued approval of atezolizumab in combination with [nab-paclitaxel] may be contingent on proven benefit of the treatment in additional trials.”
Dr. Telli explained that atezolizumab was granted accelerated approval for the treatment of PD-L1-positive TNBC based on results of the phase 3 IMpassion130 trial, which compared nab-paclitaxel plus atezolizumab with nab-paclitaxel plus placebo.
“Additional data from IMpassion131 was hoped to be used to support the conversion of the accelerated approval to a full approval. Since IMpassion131 was negative, it unfortunately places the status of atezolizumab in [TNBC] in jeopardy as the benefits were not corroborated. The FDA may move to revoke the approval of atezolizumab for [TNBC],” Dr. Telli said.
In its alert, the FDA stated that it “will review the findings of IMpassion131 and will communicate new information regarding the IMpassion131 results and any potential changes to prescribing information.”
“We need to wait for full presentation and publication of the study results, but, in my assessment, the negative results in IMpassion131 are most likely due to differences in patient selection [from IMpassion130],” Dr. Telli said.
Results from IMpassion131 are scheduled to be presented at the ESMO Virtual Congress 2020.
The IMpassion trials were funded by Roche, maker of atezolizumab. Dr. Telli disclosed relationships with AbbVie, AstraZeneca, Merck, PharmaMar, Pfizer, and Tesaro.
Pralsetinib: Second drug for RET+ NSCLC approved in U.S.
A second drug is now available in the United States for use in the treatment of patients with metastatic non–small cell lung cancer (NSCLC) that tests positive for rearranged during transfection (RET) fusions.
The new drug is pralsetinib (Gavreto). The Food and Drug Administration granted it an accelerated approval for this indication on the basis of response rate data. Continued approval for this indication depends on clinical benefit in a confirmatory trial.
Pralsetinib joins selpercatinib (Retevmo), which was approved in the United States in May 2020 as the first RET-targeted therapy. Selpercatinib is also indicated for use in RET+ NSCLC and was approved for use in RET+ medullary thyroid cancer and RET+ thyroid cancer.
Pralsetinib is still awaiting approval for these thyroid cancer indications.
Both drugs are taken orally; pralsetinib is taken once daily, and selpercatinib is taken twice daily.
For both drugs, before treatment is initiated, laboratory testing is needed to show that a RET gene alteration is present in the tumor.
RET fusions are found in approximately 1%-2% of patients with NSCLC.
They are the latest of a number of tumor-specific gene alterations found in NSCLC that are targeted with an approved drug.
“Targeted therapies have dramatically improved care for patients with non–small cell lung cancer driven by oncogenes, including EGFR and ALK, and the approval of the selective RET inhibitor pralsetinib, or Gavreto, marks another milestone in a paradigm shift toward precision medicine,” Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in a press release.
Dr. Subbiah was an investigator of the phase 1/2 clinical trial known as ARROW, which provided the data on which the accelerated approval was based. In this trial, patients with RET+ NSCLC were found by testing with next-generation sequencing, FISH (fluorescence in situ hybridization), or other methods.
The ARROW trial involved one cohort of 87 patients who had previously been treated with platinum-based chemotherapy. In these patients, the overall response rate (ORR) was 57%, the complete response (CR) rate was 5.7%, and the median duration of response (DOR) was not estimable, according to the manufacturer, Blueprint Medicines.
The trial also involved 27 treatment-naive patients who were ineligible for platinum-based chemotherapy per the study protocol. In this group, the ORR was 70%, and the CR rate was 11%. The median DOR was 9.0 months.
“Patients treated with [pralsetinib] had durable clinical responses, with a subset achieving complete responses characterized by the resolution of all target lesions, an uncommon outcome in metastatic lung cancer,” Dr. Subbiah commented.
“We observed this activity with or without prior therapy and regardless of RET fusion partner or the presence of brain metastases. This approval represents an important advance with the potential to change standards of care for patients with RET fusion-positive NSCLC, who have historically had limited treatment options,” Dr. Subbiah added.
Product information for pralsetinib has warnings and precautions of interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk for impaired wound healing, and risk for embryo-fetal toxicity.
This article first appeared on Medscape.com.
A second drug is now available in the United States for use in the treatment of patients with metastatic non–small cell lung cancer (NSCLC) that tests positive for rearranged during transfection (RET) fusions.
The new drug is pralsetinib (Gavreto). The Food and Drug Administration granted it an accelerated approval for this indication on the basis of response rate data. Continued approval for this indication depends on clinical benefit in a confirmatory trial.
Pralsetinib joins selpercatinib (Retevmo), which was approved in the United States in May 2020 as the first RET-targeted therapy. Selpercatinib is also indicated for use in RET+ NSCLC and was approved for use in RET+ medullary thyroid cancer and RET+ thyroid cancer.
Pralsetinib is still awaiting approval for these thyroid cancer indications.
Both drugs are taken orally; pralsetinib is taken once daily, and selpercatinib is taken twice daily.
For both drugs, before treatment is initiated, laboratory testing is needed to show that a RET gene alteration is present in the tumor.
RET fusions are found in approximately 1%-2% of patients with NSCLC.
They are the latest of a number of tumor-specific gene alterations found in NSCLC that are targeted with an approved drug.
“Targeted therapies have dramatically improved care for patients with non–small cell lung cancer driven by oncogenes, including EGFR and ALK, and the approval of the selective RET inhibitor pralsetinib, or Gavreto, marks another milestone in a paradigm shift toward precision medicine,” Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in a press release.
Dr. Subbiah was an investigator of the phase 1/2 clinical trial known as ARROW, which provided the data on which the accelerated approval was based. In this trial, patients with RET+ NSCLC were found by testing with next-generation sequencing, FISH (fluorescence in situ hybridization), or other methods.
The ARROW trial involved one cohort of 87 patients who had previously been treated with platinum-based chemotherapy. In these patients, the overall response rate (ORR) was 57%, the complete response (CR) rate was 5.7%, and the median duration of response (DOR) was not estimable, according to the manufacturer, Blueprint Medicines.
The trial also involved 27 treatment-naive patients who were ineligible for platinum-based chemotherapy per the study protocol. In this group, the ORR was 70%, and the CR rate was 11%. The median DOR was 9.0 months.
“Patients treated with [pralsetinib] had durable clinical responses, with a subset achieving complete responses characterized by the resolution of all target lesions, an uncommon outcome in metastatic lung cancer,” Dr. Subbiah commented.
“We observed this activity with or without prior therapy and regardless of RET fusion partner or the presence of brain metastases. This approval represents an important advance with the potential to change standards of care for patients with RET fusion-positive NSCLC, who have historically had limited treatment options,” Dr. Subbiah added.
Product information for pralsetinib has warnings and precautions of interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk for impaired wound healing, and risk for embryo-fetal toxicity.
This article first appeared on Medscape.com.
A second drug is now available in the United States for use in the treatment of patients with metastatic non–small cell lung cancer (NSCLC) that tests positive for rearranged during transfection (RET) fusions.
The new drug is pralsetinib (Gavreto). The Food and Drug Administration granted it an accelerated approval for this indication on the basis of response rate data. Continued approval for this indication depends on clinical benefit in a confirmatory trial.
Pralsetinib joins selpercatinib (Retevmo), which was approved in the United States in May 2020 as the first RET-targeted therapy. Selpercatinib is also indicated for use in RET+ NSCLC and was approved for use in RET+ medullary thyroid cancer and RET+ thyroid cancer.
Pralsetinib is still awaiting approval for these thyroid cancer indications.
Both drugs are taken orally; pralsetinib is taken once daily, and selpercatinib is taken twice daily.
For both drugs, before treatment is initiated, laboratory testing is needed to show that a RET gene alteration is present in the tumor.
RET fusions are found in approximately 1%-2% of patients with NSCLC.
They are the latest of a number of tumor-specific gene alterations found in NSCLC that are targeted with an approved drug.
“Targeted therapies have dramatically improved care for patients with non–small cell lung cancer driven by oncogenes, including EGFR and ALK, and the approval of the selective RET inhibitor pralsetinib, or Gavreto, marks another milestone in a paradigm shift toward precision medicine,” Vivek Subbiah, MD, of the University of Texas MD Anderson Cancer Center, Houston, said in a press release.
Dr. Subbiah was an investigator of the phase 1/2 clinical trial known as ARROW, which provided the data on which the accelerated approval was based. In this trial, patients with RET+ NSCLC were found by testing with next-generation sequencing, FISH (fluorescence in situ hybridization), or other methods.
The ARROW trial involved one cohort of 87 patients who had previously been treated with platinum-based chemotherapy. In these patients, the overall response rate (ORR) was 57%, the complete response (CR) rate was 5.7%, and the median duration of response (DOR) was not estimable, according to the manufacturer, Blueprint Medicines.
The trial also involved 27 treatment-naive patients who were ineligible for platinum-based chemotherapy per the study protocol. In this group, the ORR was 70%, and the CR rate was 11%. The median DOR was 9.0 months.
“Patients treated with [pralsetinib] had durable clinical responses, with a subset achieving complete responses characterized by the resolution of all target lesions, an uncommon outcome in metastatic lung cancer,” Dr. Subbiah commented.
“We observed this activity with or without prior therapy and regardless of RET fusion partner or the presence of brain metastases. This approval represents an important advance with the potential to change standards of care for patients with RET fusion-positive NSCLC, who have historically had limited treatment options,” Dr. Subbiah added.
Product information for pralsetinib has warnings and precautions of interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk for impaired wound healing, and risk for embryo-fetal toxicity.
This article first appeared on Medscape.com.
Antidepressant use shows gender, racial disparities
Women are more than twice as likely as men to use antidepressants, and use among White women is at least double that of other races/ethnicities, according to a new analysis from the National Center for Health Statistics.
Here are the actual numbers: 17.7% of women and 8.4% of men used an antidepressant in the 30 days before being interviewed for the National Health and Nutrition Examination Survey (NHANES). Put them together, and it works out to 13.2% of all adults over the 4-year period from 2015 to 2018, Debra J. Brody, MPH, and Qiuping Gu, MD, PhD, said Sept. 4 in an NCHS data brief.
Non-Hispanic White women had a past-30-day prevalence of 22.3%, compared with 10.0% for non-Hispanic Black women, 3.4% for non-Hispanic Asian women, and 8.9% for Hispanic women, based on the NHANES data.
The order was the same for men, but the numbers are lower. Non-Hispanic Whites had the highest antidepressant use at 10.5%, followed by non-Hispanic Blacks (5.0%), non-Hispanic Asians (2.1%), and Hispanics (4.0%). All of the differences between Whites and non-Whites were significant for both women and men, the researchers noted.
A look at trends over time shows that the gap between men and women has widened in the last 10 years. Past-30-day use among women went from 13.8% in 2009-2010 to 18.6% in 2017-2018, with a corresponding increase from 7.1% to 8.7% in men. For women, that change was significant; for men, it was not, Ms. Brody and Dr. Gu said.
The sample size averaged just over 6,000 for each of the five 2-year NHANES cycles included in the analysis. The survey includes a household interview and a physical examination at a mobile exam center.
Women are more than twice as likely as men to use antidepressants, and use among White women is at least double that of other races/ethnicities, according to a new analysis from the National Center for Health Statistics.
Here are the actual numbers: 17.7% of women and 8.4% of men used an antidepressant in the 30 days before being interviewed for the National Health and Nutrition Examination Survey (NHANES). Put them together, and it works out to 13.2% of all adults over the 4-year period from 2015 to 2018, Debra J. Brody, MPH, and Qiuping Gu, MD, PhD, said Sept. 4 in an NCHS data brief.
Non-Hispanic White women had a past-30-day prevalence of 22.3%, compared with 10.0% for non-Hispanic Black women, 3.4% for non-Hispanic Asian women, and 8.9% for Hispanic women, based on the NHANES data.
The order was the same for men, but the numbers are lower. Non-Hispanic Whites had the highest antidepressant use at 10.5%, followed by non-Hispanic Blacks (5.0%), non-Hispanic Asians (2.1%), and Hispanics (4.0%). All of the differences between Whites and non-Whites were significant for both women and men, the researchers noted.
A look at trends over time shows that the gap between men and women has widened in the last 10 years. Past-30-day use among women went from 13.8% in 2009-2010 to 18.6% in 2017-2018, with a corresponding increase from 7.1% to 8.7% in men. For women, that change was significant; for men, it was not, Ms. Brody and Dr. Gu said.
The sample size averaged just over 6,000 for each of the five 2-year NHANES cycles included in the analysis. The survey includes a household interview and a physical examination at a mobile exam center.
Women are more than twice as likely as men to use antidepressants, and use among White women is at least double that of other races/ethnicities, according to a new analysis from the National Center for Health Statistics.
Here are the actual numbers: 17.7% of women and 8.4% of men used an antidepressant in the 30 days before being interviewed for the National Health and Nutrition Examination Survey (NHANES). Put them together, and it works out to 13.2% of all adults over the 4-year period from 2015 to 2018, Debra J. Brody, MPH, and Qiuping Gu, MD, PhD, said Sept. 4 in an NCHS data brief.
Non-Hispanic White women had a past-30-day prevalence of 22.3%, compared with 10.0% for non-Hispanic Black women, 3.4% for non-Hispanic Asian women, and 8.9% for Hispanic women, based on the NHANES data.
The order was the same for men, but the numbers are lower. Non-Hispanic Whites had the highest antidepressant use at 10.5%, followed by non-Hispanic Blacks (5.0%), non-Hispanic Asians (2.1%), and Hispanics (4.0%). All of the differences between Whites and non-Whites were significant for both women and men, the researchers noted.
A look at trends over time shows that the gap between men and women has widened in the last 10 years. Past-30-day use among women went from 13.8% in 2009-2010 to 18.6% in 2017-2018, with a corresponding increase from 7.1% to 8.7% in men. For women, that change was significant; for men, it was not, Ms. Brody and Dr. Gu said.
The sample size averaged just over 6,000 for each of the five 2-year NHANES cycles included in the analysis. The survey includes a household interview and a physical examination at a mobile exam center.
High schoolers prefer tobacco as vapor, not smoke
according to the Centers for Disease Control and Prevention.
From 2015 to 2019, current use of electronic vapor products among students in grades 9-12 rose from 24.1% to 32.7%, while the same level of cigarette use – on 1 or more days in the previous 30 – dropped from 10.8% to 6.0%, based on data from the Youth Risk Behavior Survey.
Among the survey respondents, 50.1% had at least tried an electronic vapor product by 2019, up from 44.9% in 2015. Cigarettes again showed a decline, as ever use fell from 32.3% to 24.1%, or less than half of the e-product prevalence. Everyday use of vaping products was 7.2% in 2019 (up from 2.0% in 2015), compared with 1.1% for cigarettes (down from 2.3%), the YRBS data show.
“The dramatic increase in electronic vapor product use among high school students has led to increases in overall tobacco product use among U.S. youths, erasing gains made in previous years and leading the U.S. Surgeon General to declare youth e-cigarette use an epidemic in the United States,” MeLisa R. Creamer, PhD, and associates at the CDC wrote in the MMWR.
Electronic vapor products, as defined by the survey, “include e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, and mods.”
Current use of cigarettes among high school students, as measured by the YRBS, has been declining since reaching a high of 36.4% in 1997; the prevalence of everyday use peaked at 12.8% in 1999. Current use of cigars declined as well, falling from 17.7% in 1999 to 5.7% in 2019, according to YRBS data.
“In 2019, a total of 36.5% of high school students currently used any tobacco product, with electronic vapor products being the most commonly used product,” Dr. Creamer and associates wrote in their recent analysis of the YRBS data (MMWR Supp. 2020 Aug 21;69[1]:56-63).
For the first time since the use of electronic vapor products was included in the every-other-year survey in 2015, females were more likely than males to be current users of vaping products last year, 33.5% to 32.0%. Males were heavier users of cigarettes by a margin of 6.9% to 4.9%, the CDC reported.
Geographically speaking, use of both electronic vapor products and cigarettes varied considerably among the 43 states with available data. Current use of electronic products ranged from a low of 9.7% in Utah to a high of 35.7% in West Virginia, with the two states in the same positions regarding current cigarette use: Utah (2.2%) lowest and West Virginia (13.5%) highest, based on the 2019 YRBS data.
“Tobacco product usage has evolved, and the increasing prevalence of electronic vapor product use among youths during recent years is concerning,” Dr. Creamer and associates wrote.
according to the Centers for Disease Control and Prevention.
From 2015 to 2019, current use of electronic vapor products among students in grades 9-12 rose from 24.1% to 32.7%, while the same level of cigarette use – on 1 or more days in the previous 30 – dropped from 10.8% to 6.0%, based on data from the Youth Risk Behavior Survey.
Among the survey respondents, 50.1% had at least tried an electronic vapor product by 2019, up from 44.9% in 2015. Cigarettes again showed a decline, as ever use fell from 32.3% to 24.1%, or less than half of the e-product prevalence. Everyday use of vaping products was 7.2% in 2019 (up from 2.0% in 2015), compared with 1.1% for cigarettes (down from 2.3%), the YRBS data show.
“The dramatic increase in electronic vapor product use among high school students has led to increases in overall tobacco product use among U.S. youths, erasing gains made in previous years and leading the U.S. Surgeon General to declare youth e-cigarette use an epidemic in the United States,” MeLisa R. Creamer, PhD, and associates at the CDC wrote in the MMWR.
Electronic vapor products, as defined by the survey, “include e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, and mods.”
Current use of cigarettes among high school students, as measured by the YRBS, has been declining since reaching a high of 36.4% in 1997; the prevalence of everyday use peaked at 12.8% in 1999. Current use of cigars declined as well, falling from 17.7% in 1999 to 5.7% in 2019, according to YRBS data.
“In 2019, a total of 36.5% of high school students currently used any tobacco product, with electronic vapor products being the most commonly used product,” Dr. Creamer and associates wrote in their recent analysis of the YRBS data (MMWR Supp. 2020 Aug 21;69[1]:56-63).
For the first time since the use of electronic vapor products was included in the every-other-year survey in 2015, females were more likely than males to be current users of vaping products last year, 33.5% to 32.0%. Males were heavier users of cigarettes by a margin of 6.9% to 4.9%, the CDC reported.
Geographically speaking, use of both electronic vapor products and cigarettes varied considerably among the 43 states with available data. Current use of electronic products ranged from a low of 9.7% in Utah to a high of 35.7% in West Virginia, with the two states in the same positions regarding current cigarette use: Utah (2.2%) lowest and West Virginia (13.5%) highest, based on the 2019 YRBS data.
“Tobacco product usage has evolved, and the increasing prevalence of electronic vapor product use among youths during recent years is concerning,” Dr. Creamer and associates wrote.
according to the Centers for Disease Control and Prevention.
From 2015 to 2019, current use of electronic vapor products among students in grades 9-12 rose from 24.1% to 32.7%, while the same level of cigarette use – on 1 or more days in the previous 30 – dropped from 10.8% to 6.0%, based on data from the Youth Risk Behavior Survey.
Among the survey respondents, 50.1% had at least tried an electronic vapor product by 2019, up from 44.9% in 2015. Cigarettes again showed a decline, as ever use fell from 32.3% to 24.1%, or less than half of the e-product prevalence. Everyday use of vaping products was 7.2% in 2019 (up from 2.0% in 2015), compared with 1.1% for cigarettes (down from 2.3%), the YRBS data show.
“The dramatic increase in electronic vapor product use among high school students has led to increases in overall tobacco product use among U.S. youths, erasing gains made in previous years and leading the U.S. Surgeon General to declare youth e-cigarette use an epidemic in the United States,” MeLisa R. Creamer, PhD, and associates at the CDC wrote in the MMWR.
Electronic vapor products, as defined by the survey, “include e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, and mods.”
Current use of cigarettes among high school students, as measured by the YRBS, has been declining since reaching a high of 36.4% in 1997; the prevalence of everyday use peaked at 12.8% in 1999. Current use of cigars declined as well, falling from 17.7% in 1999 to 5.7% in 2019, according to YRBS data.
“In 2019, a total of 36.5% of high school students currently used any tobacco product, with electronic vapor products being the most commonly used product,” Dr. Creamer and associates wrote in their recent analysis of the YRBS data (MMWR Supp. 2020 Aug 21;69[1]:56-63).
For the first time since the use of electronic vapor products was included in the every-other-year survey in 2015, females were more likely than males to be current users of vaping products last year, 33.5% to 32.0%. Males were heavier users of cigarettes by a margin of 6.9% to 4.9%, the CDC reported.
Geographically speaking, use of both electronic vapor products and cigarettes varied considerably among the 43 states with available data. Current use of electronic products ranged from a low of 9.7% in Utah to a high of 35.7% in West Virginia, with the two states in the same positions regarding current cigarette use: Utah (2.2%) lowest and West Virginia (13.5%) highest, based on the 2019 YRBS data.
“Tobacco product usage has evolved, and the increasing prevalence of electronic vapor product use among youths during recent years is concerning,” Dr. Creamer and associates wrote.
FDA expands remdesivir use for all COVID-19 hospitalized patients
An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.
“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
‘Further evaluation’ needed
The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.
The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.
Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.
Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].
“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.
“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.
The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.
For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
This article first appeared on Medscape.com.
An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.
“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
‘Further evaluation’ needed
The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.
The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.
Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.
Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].
“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.
“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.
The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.
For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
This article first appeared on Medscape.com.
An EUA of remdesivir issued in May allowed the drug to be used only for patients with severe COVID-19, specifically, COVID-19 patients with low blood oxygen levels or who need oxygen therapy or mechanical ventilation.
“Today, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients,” the FDA news release about the expanded EUA said. “The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
‘Further evaluation’ needed
The EUA expansion is partially based on the results of a randomized, open-label trial that Gilead Sciences, remdesivir’s manufacturer, conducted at multiple sites.
The trial showed that a 5-day course of remdesivir was associated with statistically significant improvement among patients hospitalized with moderate COVID-19 in comparison with those receiving standard care. However, patients who were randomly assigned to a receive longer, 10-day remdesivir course had not improved significantly 11 days after treatment started, compared with those who received standard care.
Results with remdesivir in this trial and in two previously reported randomized trials varied, “raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” wrote Erin K. McCreary, PharmD, and Derek C. Angus, MD, MPH, with the University of Pittsburgh School of Medicine, in an editorial that accompanied publication of the trials in JAMA.
Angus previously expressed concern that expanding remdesivir’s EUA could “interrupt or thwart efforts to execute the needed RCTs [randomized controlled trials].
“We think there really needs to be further evaluation of remdesivir in large-scale RCTs adequately powered to understand in which patients, at which dose, given at which point in the course of illness leads to what concrete and tangible improvement in clinical outcomes,” he told Medscape Medical News.
“At this point, remdesivir definitely holds promise, but given the cost to produce and distribute the drug, it seems crucial to know with more certainty how best to use it,” Angus said.
The EUA expansion is also partially based on results from a randomized, double-blind, placebo-controlled clinical trial that the National Institutes of Allergy and Infectious Diseases conducted. In that trial, there was a statistically significant reduction in median recovery time and higher odds of clinical improvement after 2 weeks for hospitalized patients who received remdesivir.
For hospitalized patients with mild to moderate disease, the results were consistent with the overall study results but were not statistically significant.
This article first appeared on Medscape.com.
FDA approves point-of-care COVID-19 antigen test
The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.
A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.
Abbott expects the test to cost about $5.00, the company announced.
Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”
“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.
The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.
The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.
Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.
Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
This article first appeared on Medscape.com.
The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.
A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.
Abbott expects the test to cost about $5.00, the company announced.
Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”
“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.
The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.
The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.
Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.
Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
This article first appeared on Medscape.com.
The BinaxNOW COVID-19 Ag Card (Abbott) is similar in some ways to a home pregnancy test. Clinicians read results on a card – one line for a negative result, two lines for positive.
A health care provider swabs a symptomatic patient’s nose, twirls the sample on a test card with a reagent, and waits approximately 15 minutes for results. No additional equipment is required.
Abbott expects the test to cost about $5.00, the company announced.
Office-based physicians, ED physicians, and school nurses could potentially use the product as a point-of-care test. The FDA granted the test emergency use authorization. It is approved for people suspected of having COVID-19 who are within 7 days of symptom onset.
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, wrote in a news release. “This means people will know if they have the virus in almost real time.”
“This fits into the testing landscape as a simple, inexpensive test that does not require additional equipment,” Marcus Lynch, PhD, assistant manager of the Health Care Horizon Scanning program at ECRI, told Medscape Medical News when asked to comment. ECRI is an independent, nonprofit organization that reviews and analyses COVID-19 therapeutics and diagnostics.
The test could help with early triage of patients who test positive, perhaps alerting physicians to the need to start COVID-19 therapy, added Lynch, who specializes in immunology and vaccine development. The test also could be useful in low-resource settings.
The FDA included a caveat: antigen tests are generally less sensitive than molecular assays. “Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the agency noted.
Lynch agreed and said that when a patient tests negative, physicians still need to use their clinical judgment on the basis of symptoms and other factors. The test is not designed for population-based screening of asymptomatic people, he added.
Abbott announced plans to make up to 50 million tests available per month in the United States starting in October. The product comes with a free smartphone app that people can use to share results with an employer or with others as needed.
This article first appeared on Medscape.com.
FDA approves clinical trials for cannabinoid drug designed to reduce COVID-19 lung inflammation
The US Food and Drug Administration has approved phase one clinical trials for a synthetic cannabinoid drug designed to treat acute respiratory distress syndrome (ARDS), a life-threatening lung condition which may occur in severe cases of the novel coronavirus, Forbes reported.
ARDS can be triggered by over-creation of cytokines, proteins which tell the body to produce more inflammation, Forbes said.
The drug going to clinical trials, ARDS-003, would “dampen the cytokine release” and prevent development of ARDS, Tetra Bio-Pharma company CEO and chief regulatory officer Guy Chamberland, MD, said in a news release.
Consequences of ARDS include scarring of the lungs and organ injury caused by the decrease in blood to the tissue, the release said.
“The FDA repeatedly stated that they want clinical trials for COVID-19 to begin as soon as possible, as long as they meet regulatory requirements,” the news release said. “The medical community is in urgent need of drugs that can reduce the strength and duration of the severe inflammation. It is anticipated that this type of new drug would favorably impact health care and possibly reduce the negative health outcomes post infection.”
ARDS-003 works by binding to CB2 receptors, one of two main receptors in the endocannabinoid system which modulate inflammation and cytokine activity, Forbes said. CB2 receptors don’t bring on a psychoactive high.
Phase one clinical trials would begin enrolling participants in December to determine if the drug is safe, Chamberland said, according to Forbes.
If phase one is successful, phase two would test the drug on a larger group in the second quarter of 2021 to assess safety and tolerability for people who have COVID-19.
If phase two is successful, the company may seek emergency authorization through the FDA, Chamberland said. Phase three would start at the end of 2021.
Tetra Bio-Pharma says it has already contracted with Dalton Pharma Services to manufacture the active pharmaceutical ingredient (API), HU-308, and the finished drug product ARDS-003.
This article first appeared on Medscape.com.
The US Food and Drug Administration has approved phase one clinical trials for a synthetic cannabinoid drug designed to treat acute respiratory distress syndrome (ARDS), a life-threatening lung condition which may occur in severe cases of the novel coronavirus, Forbes reported.
ARDS can be triggered by over-creation of cytokines, proteins which tell the body to produce more inflammation, Forbes said.
The drug going to clinical trials, ARDS-003, would “dampen the cytokine release” and prevent development of ARDS, Tetra Bio-Pharma company CEO and chief regulatory officer Guy Chamberland, MD, said in a news release.
Consequences of ARDS include scarring of the lungs and organ injury caused by the decrease in blood to the tissue, the release said.
“The FDA repeatedly stated that they want clinical trials for COVID-19 to begin as soon as possible, as long as they meet regulatory requirements,” the news release said. “The medical community is in urgent need of drugs that can reduce the strength and duration of the severe inflammation. It is anticipated that this type of new drug would favorably impact health care and possibly reduce the negative health outcomes post infection.”
ARDS-003 works by binding to CB2 receptors, one of two main receptors in the endocannabinoid system which modulate inflammation and cytokine activity, Forbes said. CB2 receptors don’t bring on a psychoactive high.
Phase one clinical trials would begin enrolling participants in December to determine if the drug is safe, Chamberland said, according to Forbes.
If phase one is successful, phase two would test the drug on a larger group in the second quarter of 2021 to assess safety and tolerability for people who have COVID-19.
If phase two is successful, the company may seek emergency authorization through the FDA, Chamberland said. Phase three would start at the end of 2021.
Tetra Bio-Pharma says it has already contracted with Dalton Pharma Services to manufacture the active pharmaceutical ingredient (API), HU-308, and the finished drug product ARDS-003.
This article first appeared on Medscape.com.
The US Food and Drug Administration has approved phase one clinical trials for a synthetic cannabinoid drug designed to treat acute respiratory distress syndrome (ARDS), a life-threatening lung condition which may occur in severe cases of the novel coronavirus, Forbes reported.
ARDS can be triggered by over-creation of cytokines, proteins which tell the body to produce more inflammation, Forbes said.
The drug going to clinical trials, ARDS-003, would “dampen the cytokine release” and prevent development of ARDS, Tetra Bio-Pharma company CEO and chief regulatory officer Guy Chamberland, MD, said in a news release.
Consequences of ARDS include scarring of the lungs and organ injury caused by the decrease in blood to the tissue, the release said.
“The FDA repeatedly stated that they want clinical trials for COVID-19 to begin as soon as possible, as long as they meet regulatory requirements,” the news release said. “The medical community is in urgent need of drugs that can reduce the strength and duration of the severe inflammation. It is anticipated that this type of new drug would favorably impact health care and possibly reduce the negative health outcomes post infection.”
ARDS-003 works by binding to CB2 receptors, one of two main receptors in the endocannabinoid system which modulate inflammation and cytokine activity, Forbes said. CB2 receptors don’t bring on a psychoactive high.
Phase one clinical trials would begin enrolling participants in December to determine if the drug is safe, Chamberland said, according to Forbes.
If phase one is successful, phase two would test the drug on a larger group in the second quarter of 2021 to assess safety and tolerability for people who have COVID-19.
If phase two is successful, the company may seek emergency authorization through the FDA, Chamberland said. Phase three would start at the end of 2021.
Tetra Bio-Pharma says it has already contracted with Dalton Pharma Services to manufacture the active pharmaceutical ingredient (API), HU-308, and the finished drug product ARDS-003.
This article first appeared on Medscape.com.