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Children and COVID: New cases increase; hospital admissions could follow
New cases of COVID-19 in children were up again after 2 weeks of declines, and preliminary data suggest that hospitalizations may be on the rise as well.
, based on data collected by the American Academy of Pediatrics and the Children’s Hospital Association from state and territorial health departments.
A similar increase seems to be reflected by hospital-level data. The latest 7-day (Aug. 21-27) average is 305 new admissions with diagnosed COVID per day among children aged 0-17 years, compared with 290 per day for the week of Aug. 14-20, the Centers for Disease Control and Prevention reported, while also noting the potential for reporting delays in the most recent 7-day period.
Daily hospital admissions for COVID had been headed downward through the first half of August, falling from 0.46 per 100,000 population at the end of July to 0.40 on Aug. 19, the CDC said on its COVID Data Tracker. Since then, however, admissions have gone the other way, with the preliminary nature of the latest data suggesting that the numbers will be even higher as more hospitals report over the next few days.
Vaccine initiations continue to fall
Initiations among school-age children have fallen for 3 consecutive weeks since Aug. 3, when numbers receiving their first vaccinations reached late-summer highs for those aged 5-11 and 12-17 years. Children under age 5, included in the CDC data for the first time on Aug. 11 as separate groups – under 2 years and 2-4 years – have had vaccine initiations drop by 8.0% and 19.8% over the 2 following weeks, the CDC said.
Through their first 8 weeks of vaccine eligibility (June 19 to Aug. 15), 4.8% of children under 5 years of age had received a first vaccination and 1.0% were fully vaccinated. For the two other age groups (5-11 and 12-15) who became eligible after the very first emergency authorization back in 2020, the respective proportions were 25.0% and 16.0% (5-11) and 33.8% and 26.1% (12-15) through the first 8 weeks, according to CDC data.
New cases of COVID-19 in children were up again after 2 weeks of declines, and preliminary data suggest that hospitalizations may be on the rise as well.
, based on data collected by the American Academy of Pediatrics and the Children’s Hospital Association from state and territorial health departments.
A similar increase seems to be reflected by hospital-level data. The latest 7-day (Aug. 21-27) average is 305 new admissions with diagnosed COVID per day among children aged 0-17 years, compared with 290 per day for the week of Aug. 14-20, the Centers for Disease Control and Prevention reported, while also noting the potential for reporting delays in the most recent 7-day period.
Daily hospital admissions for COVID had been headed downward through the first half of August, falling from 0.46 per 100,000 population at the end of July to 0.40 on Aug. 19, the CDC said on its COVID Data Tracker. Since then, however, admissions have gone the other way, with the preliminary nature of the latest data suggesting that the numbers will be even higher as more hospitals report over the next few days.
Vaccine initiations continue to fall
Initiations among school-age children have fallen for 3 consecutive weeks since Aug. 3, when numbers receiving their first vaccinations reached late-summer highs for those aged 5-11 and 12-17 years. Children under age 5, included in the CDC data for the first time on Aug. 11 as separate groups – under 2 years and 2-4 years – have had vaccine initiations drop by 8.0% and 19.8% over the 2 following weeks, the CDC said.
Through their first 8 weeks of vaccine eligibility (June 19 to Aug. 15), 4.8% of children under 5 years of age had received a first vaccination and 1.0% were fully vaccinated. For the two other age groups (5-11 and 12-15) who became eligible after the very first emergency authorization back in 2020, the respective proportions were 25.0% and 16.0% (5-11) and 33.8% and 26.1% (12-15) through the first 8 weeks, according to CDC data.
New cases of COVID-19 in children were up again after 2 weeks of declines, and preliminary data suggest that hospitalizations may be on the rise as well.
, based on data collected by the American Academy of Pediatrics and the Children’s Hospital Association from state and territorial health departments.
A similar increase seems to be reflected by hospital-level data. The latest 7-day (Aug. 21-27) average is 305 new admissions with diagnosed COVID per day among children aged 0-17 years, compared with 290 per day for the week of Aug. 14-20, the Centers for Disease Control and Prevention reported, while also noting the potential for reporting delays in the most recent 7-day period.
Daily hospital admissions for COVID had been headed downward through the first half of August, falling from 0.46 per 100,000 population at the end of July to 0.40 on Aug. 19, the CDC said on its COVID Data Tracker. Since then, however, admissions have gone the other way, with the preliminary nature of the latest data suggesting that the numbers will be even higher as more hospitals report over the next few days.
Vaccine initiations continue to fall
Initiations among school-age children have fallen for 3 consecutive weeks since Aug. 3, when numbers receiving their first vaccinations reached late-summer highs for those aged 5-11 and 12-17 years. Children under age 5, included in the CDC data for the first time on Aug. 11 as separate groups – under 2 years and 2-4 years – have had vaccine initiations drop by 8.0% and 19.8% over the 2 following weeks, the CDC said.
Through their first 8 weeks of vaccine eligibility (June 19 to Aug. 15), 4.8% of children under 5 years of age had received a first vaccination and 1.0% were fully vaccinated. For the two other age groups (5-11 and 12-15) who became eligible after the very first emergency authorization back in 2020, the respective proportions were 25.0% and 16.0% (5-11) and 33.8% and 26.1% (12-15) through the first 8 weeks, according to CDC data.
COVID to blame as U.S. life expectancy falls
All 50 states and the District of Columbia saw drops in life expectancy, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
The declines were mostly because of COVID-19 and “unintentional injuries,” such as drug overdoses.
The overall drop took national life expectancy from 78.8 years in 2019 to 77 years in 2020, the first year of the pandemic, ABC News reported.
States in the West and Northwest generally had higher life expectancy, with states in the South having the lowest.
Hawaii had the highest life expectancy at 80.7 years. It was followed by Washington, Minnesota, California, and Massachusetts. Mississippi had the lowest at 71.9 years, the figures show. The others in the bottom five were West Virginia, Louisiana, Alabama, and Kentucky.
In 2020, COVID-19 was the third-highest cause of death, leading to more than 350,000, the CDC reported earlier this year. At the same time, more people are dying annually from drug overdoses. A record 83,500 fatal overdoses were reported in 2020.
A version of this article first appeared on WebMD.com.
All 50 states and the District of Columbia saw drops in life expectancy, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
The declines were mostly because of COVID-19 and “unintentional injuries,” such as drug overdoses.
The overall drop took national life expectancy from 78.8 years in 2019 to 77 years in 2020, the first year of the pandemic, ABC News reported.
States in the West and Northwest generally had higher life expectancy, with states in the South having the lowest.
Hawaii had the highest life expectancy at 80.7 years. It was followed by Washington, Minnesota, California, and Massachusetts. Mississippi had the lowest at 71.9 years, the figures show. The others in the bottom five were West Virginia, Louisiana, Alabama, and Kentucky.
In 2020, COVID-19 was the third-highest cause of death, leading to more than 350,000, the CDC reported earlier this year. At the same time, more people are dying annually from drug overdoses. A record 83,500 fatal overdoses were reported in 2020.
A version of this article first appeared on WebMD.com.
All 50 states and the District of Columbia saw drops in life expectancy, according to the report from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
The declines were mostly because of COVID-19 and “unintentional injuries,” such as drug overdoses.
The overall drop took national life expectancy from 78.8 years in 2019 to 77 years in 2020, the first year of the pandemic, ABC News reported.
States in the West and Northwest generally had higher life expectancy, with states in the South having the lowest.
Hawaii had the highest life expectancy at 80.7 years. It was followed by Washington, Minnesota, California, and Massachusetts. Mississippi had the lowest at 71.9 years, the figures show. The others in the bottom five were West Virginia, Louisiana, Alabama, and Kentucky.
In 2020, COVID-19 was the third-highest cause of death, leading to more than 350,000, the CDC reported earlier this year. At the same time, more people are dying annually from drug overdoses. A record 83,500 fatal overdoses were reported in 2020.
A version of this article first appeared on WebMD.com.
Children and COVID: New cases fall again, ED rates rebound for some
The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.
That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.
There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
Weekly cases fall below 80,000
New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).
The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.
Most younger children still not vaccinated
Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.
Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.
The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.
That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.
There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
Weekly cases fall below 80,000
New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).
The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.
Most younger children still not vaccinated
Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.
Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.
The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.
That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.
There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
Weekly cases fall below 80,000
New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).
The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.
Most younger children still not vaccinated
Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.
Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.
FDA approves first gene therapy, betibeglogene autotemcel (Zynteglo), for beta-thalassemia
Betibeglogene autotemcel, a one-time gene therapy, represents a potential cure in which functional copies of the mutated gene are inserted into patients’ hematopoietic stem cells via a replication-defective lentivirus.
“Today’s approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA press release. “Given the potential health complications associated with this serious disease, this action highlights the FDA’s continued commitment to supporting development of innovative therapies for patients who have limited treatment options.”
The approval was based on phase 3 trials, in which 89% of 41 patients aged 4-34 years who received the therapy maintained normal or near-normal hemoglobin levels and didn’t need transfusions for at least a year. The patients were as young as age 4, maker Bluebird Bio said in a press release.
FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee unanimously recommended approval in June. The gene therapy had been approved in Europe, where it carried a price tag of about $1.8 million, but Bluebird pulled it from the market in 2021 because of problems with reimbursement.
“The decision to discontinue operations in Europe resulted from prolonged negotiations with European payers and challenges to achieving appropriate value recognition and market access,” the company said in a Securities and Exchange Commission filing.
The projected price in the United States is even higher: $2.1 million.
But the Institute for Clinical and Economic Review, an influential Boston-based nonprofit organization that specializes in medical cost-effectiveness analyses, concluded in June that, “given the high annual costs of standard care ... this new treatment meets commonly accepted value thresholds at an anticipated price of $2.1 million,” particularly with Bluebird’s proposal to pay back 80% of the cost if patients need a transfusion within 5 years.
The company is planning an October 2022 launch and estimates the U.S. market for betibeglogene autotemcel to be about 1,500 patients.
Adverse events in studies were “infrequent and consisted primarily of nonserious infusion-related reactions,” such as abdominal pain, hot flush, dyspnea, tachycardia, noncardiac chest pain, and cytopenias, including thrombocytopenia, leukopenia, and neutropenia. One case of thrombocytopenia was considered serious but resolved, according to the company.
Most of the serious adverse events were related to hematopoietic stem cell collection and the busulfan conditioning regimen. Insertional oncogenesis and/or cancer have been reported with Bluebird’s other gene therapy products, but no cases have been associated with betibeglogene autotemcel.
A version of this article first appeared on Medscape.com.
Betibeglogene autotemcel, a one-time gene therapy, represents a potential cure in which functional copies of the mutated gene are inserted into patients’ hematopoietic stem cells via a replication-defective lentivirus.
“Today’s approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA press release. “Given the potential health complications associated with this serious disease, this action highlights the FDA’s continued commitment to supporting development of innovative therapies for patients who have limited treatment options.”
The approval was based on phase 3 trials, in which 89% of 41 patients aged 4-34 years who received the therapy maintained normal or near-normal hemoglobin levels and didn’t need transfusions for at least a year. The patients were as young as age 4, maker Bluebird Bio said in a press release.
FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee unanimously recommended approval in June. The gene therapy had been approved in Europe, where it carried a price tag of about $1.8 million, but Bluebird pulled it from the market in 2021 because of problems with reimbursement.
“The decision to discontinue operations in Europe resulted from prolonged negotiations with European payers and challenges to achieving appropriate value recognition and market access,” the company said in a Securities and Exchange Commission filing.
The projected price in the United States is even higher: $2.1 million.
But the Institute for Clinical and Economic Review, an influential Boston-based nonprofit organization that specializes in medical cost-effectiveness analyses, concluded in June that, “given the high annual costs of standard care ... this new treatment meets commonly accepted value thresholds at an anticipated price of $2.1 million,” particularly with Bluebird’s proposal to pay back 80% of the cost if patients need a transfusion within 5 years.
The company is planning an October 2022 launch and estimates the U.S. market for betibeglogene autotemcel to be about 1,500 patients.
Adverse events in studies were “infrequent and consisted primarily of nonserious infusion-related reactions,” such as abdominal pain, hot flush, dyspnea, tachycardia, noncardiac chest pain, and cytopenias, including thrombocytopenia, leukopenia, and neutropenia. One case of thrombocytopenia was considered serious but resolved, according to the company.
Most of the serious adverse events were related to hematopoietic stem cell collection and the busulfan conditioning regimen. Insertional oncogenesis and/or cancer have been reported with Bluebird’s other gene therapy products, but no cases have been associated with betibeglogene autotemcel.
A version of this article first appeared on Medscape.com.
Betibeglogene autotemcel, a one-time gene therapy, represents a potential cure in which functional copies of the mutated gene are inserted into patients’ hematopoietic stem cells via a replication-defective lentivirus.
“Today’s approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA press release. “Given the potential health complications associated with this serious disease, this action highlights the FDA’s continued commitment to supporting development of innovative therapies for patients who have limited treatment options.”
The approval was based on phase 3 trials, in which 89% of 41 patients aged 4-34 years who received the therapy maintained normal or near-normal hemoglobin levels and didn’t need transfusions for at least a year. The patients were as young as age 4, maker Bluebird Bio said in a press release.
FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee unanimously recommended approval in June. The gene therapy had been approved in Europe, where it carried a price tag of about $1.8 million, but Bluebird pulled it from the market in 2021 because of problems with reimbursement.
“The decision to discontinue operations in Europe resulted from prolonged negotiations with European payers and challenges to achieving appropriate value recognition and market access,” the company said in a Securities and Exchange Commission filing.
The projected price in the United States is even higher: $2.1 million.
But the Institute for Clinical and Economic Review, an influential Boston-based nonprofit organization that specializes in medical cost-effectiveness analyses, concluded in June that, “given the high annual costs of standard care ... this new treatment meets commonly accepted value thresholds at an anticipated price of $2.1 million,” particularly with Bluebird’s proposal to pay back 80% of the cost if patients need a transfusion within 5 years.
The company is planning an October 2022 launch and estimates the U.S. market for betibeglogene autotemcel to be about 1,500 patients.
Adverse events in studies were “infrequent and consisted primarily of nonserious infusion-related reactions,” such as abdominal pain, hot flush, dyspnea, tachycardia, noncardiac chest pain, and cytopenias, including thrombocytopenia, leukopenia, and neutropenia. One case of thrombocytopenia was considered serious but resolved, according to the company.
Most of the serious adverse events were related to hematopoietic stem cell collection and the busulfan conditioning regimen. Insertional oncogenesis and/or cancer have been reported with Bluebird’s other gene therapy products, but no cases have been associated with betibeglogene autotemcel.
A version of this article first appeared on Medscape.com.
FDA approves adalimumab-bwwd biosimilar (Hadlima) in high-concentration form
The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.
Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).
Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.
The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.
The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.
Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.
The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.
A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.
Patients taking Hadlima should not take a live vaccine.
The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.
Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).
Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.
The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.
The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.
Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.
The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.
A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.
Patients taking Hadlima should not take a live vaccine.
The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration today approved a citrate-free, high-concentration formulation of adalimumab-bwwd (Hadlima), the manufacturer, Samsung Bioepis, and its commercialization partner Organon said in an announcement.
Hadlima is a biosimilar of the tumor necrosis factor inhibitor reference product adalimumab (Humira).
Hadlima was first approved in July 2019 in a citrated, 50-mg/mL formulation. The new citrate-free, 100-mg/mL version will be available in prefilled syringe and autoinjector options.
The 100-mg/mL formulation is indicated for the same seven conditions as its 50-mg/mL counterpart: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, and ulcerative colitis.
The approval was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the 100-mg/mL and 50-mg/mL formulations of Hadlima in healthy volunteers.
Both low- and high-concentration formulations of Humira are currently marketed in the United States. Organon said that it expects to market Hadlima in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.
The prescribing information for Hadlima includes specific warnings and areas of concern. The drug should not be administered to individuals who are known to be hypersensitive to adalimumab. The drug may lower the ability of the immune system to fight infections and may increase risk of infections, including serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections attributable to other opportunistic pathogens.
A test for latent TB infection should be given before administration, and treatment of TB should begin before administration of Hadlima.
Patients taking Hadlima should not take a live vaccine.
The most common adverse effects (incidence > 10%) include infections (for example, upper respiratory infections, sinusitis), injection site reactions, headache, and rash.
A version of this article first appeared on Medscape.com.
Children and COVID: ED visits and new admissions change course
New child cases of COVID-19 made at least a temporary transition from slow increase to decrease, and emergency department visits and new admissions seem to be following a downward trend.
, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. For some historical perspective, the latest weekly count falls below last year’s Delta surge figure of 121,000 (Aug. 6-12) but above the summer 2020 total of 26,000 (Aug. 7-13).
Measures of serious illness finally head downward
The prolonged rise in ED visits and new admissions over the last 5 months, which continued even through late spring when cases were declining, seems to have peaked, CDC data suggest.
That upward trend, driven largely by continued increases among younger children, peaked in late July, when 6.7% of all ED visits for children aged 0-11 years involved diagnosed COVID-19. The corresponding peaks for older children occurred around the same time but were only about half as high: 3.4% for 12- to 15-year-olds and 3.6% for those aged 16-17, the CDC reported.
The data for new admissions present a similar scenario: an increase starting in mid-April that continued unabated into late July despite the decline in new cases. By the time admissions among children aged 0-17 years peaked at 0.46 per 100,000 population in late July, they had reached the same level seen during the Delta surge. By Aug. 7, the rate of new hospitalizations was down to 0.42 per 100,000, the CDC said on its COVID Data Tracker.
The vaccine is ready for all students, but …
As children all over the country start or get ready to start a new school year, the only large-scale student vaccine mandate belongs to the District of Columbia. California has a mandate pending, but it will not go into effect until after July 1, 2023. There are, however, 20 states that have banned vaccine mandates for students, according to the National Academy for State Health Policy.
Nonmandated vaccination of the youngest children against COVID-19 continues to be slow. In the approximately 7 weeks (June 19 to Aug. 9) since the vaccine was approved for use in children younger than 5 years, just 4.4% of that age group has received at least one dose and 0.7% are fully vaccinated. Among those aged 5-11 years, who have been vaccine-eligible since early November of last year, 37.6% have received at least one dose and 30.2% are fully vaccinated, the CDC said.
New child cases of COVID-19 made at least a temporary transition from slow increase to decrease, and emergency department visits and new admissions seem to be following a downward trend.
, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. For some historical perspective, the latest weekly count falls below last year’s Delta surge figure of 121,000 (Aug. 6-12) but above the summer 2020 total of 26,000 (Aug. 7-13).
Measures of serious illness finally head downward
The prolonged rise in ED visits and new admissions over the last 5 months, which continued even through late spring when cases were declining, seems to have peaked, CDC data suggest.
That upward trend, driven largely by continued increases among younger children, peaked in late July, when 6.7% of all ED visits for children aged 0-11 years involved diagnosed COVID-19. The corresponding peaks for older children occurred around the same time but were only about half as high: 3.4% for 12- to 15-year-olds and 3.6% for those aged 16-17, the CDC reported.
The data for new admissions present a similar scenario: an increase starting in mid-April that continued unabated into late July despite the decline in new cases. By the time admissions among children aged 0-17 years peaked at 0.46 per 100,000 population in late July, they had reached the same level seen during the Delta surge. By Aug. 7, the rate of new hospitalizations was down to 0.42 per 100,000, the CDC said on its COVID Data Tracker.
The vaccine is ready for all students, but …
As children all over the country start or get ready to start a new school year, the only large-scale student vaccine mandate belongs to the District of Columbia. California has a mandate pending, but it will not go into effect until after July 1, 2023. There are, however, 20 states that have banned vaccine mandates for students, according to the National Academy for State Health Policy.
Nonmandated vaccination of the youngest children against COVID-19 continues to be slow. In the approximately 7 weeks (June 19 to Aug. 9) since the vaccine was approved for use in children younger than 5 years, just 4.4% of that age group has received at least one dose and 0.7% are fully vaccinated. Among those aged 5-11 years, who have been vaccine-eligible since early November of last year, 37.6% have received at least one dose and 30.2% are fully vaccinated, the CDC said.
New child cases of COVID-19 made at least a temporary transition from slow increase to decrease, and emergency department visits and new admissions seem to be following a downward trend.
, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association. For some historical perspective, the latest weekly count falls below last year’s Delta surge figure of 121,000 (Aug. 6-12) but above the summer 2020 total of 26,000 (Aug. 7-13).
Measures of serious illness finally head downward
The prolonged rise in ED visits and new admissions over the last 5 months, which continued even through late spring when cases were declining, seems to have peaked, CDC data suggest.
That upward trend, driven largely by continued increases among younger children, peaked in late July, when 6.7% of all ED visits for children aged 0-11 years involved diagnosed COVID-19. The corresponding peaks for older children occurred around the same time but were only about half as high: 3.4% for 12- to 15-year-olds and 3.6% for those aged 16-17, the CDC reported.
The data for new admissions present a similar scenario: an increase starting in mid-April that continued unabated into late July despite the decline in new cases. By the time admissions among children aged 0-17 years peaked at 0.46 per 100,000 population in late July, they had reached the same level seen during the Delta surge. By Aug. 7, the rate of new hospitalizations was down to 0.42 per 100,000, the CDC said on its COVID Data Tracker.
The vaccine is ready for all students, but …
As children all over the country start or get ready to start a new school year, the only large-scale student vaccine mandate belongs to the District of Columbia. California has a mandate pending, but it will not go into effect until after July 1, 2023. There are, however, 20 states that have banned vaccine mandates for students, according to the National Academy for State Health Policy.
Nonmandated vaccination of the youngest children against COVID-19 continues to be slow. In the approximately 7 weeks (June 19 to Aug. 9) since the vaccine was approved for use in children younger than 5 years, just 4.4% of that age group has received at least one dose and 0.7% are fully vaccinated. Among those aged 5-11 years, who have been vaccine-eligible since early November of last year, 37.6% have received at least one dose and 30.2% are fully vaccinated, the CDC said.
U.S. tops 10,000 confirmed monkeypox cases: CDC
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
The United States passed the 10,000 mark on Aug. 10, with the number climbing to 10,768 by the morning of Aug. 12, according to the latest CDC data. Monkeypox cases have been found in every state except Wyoming. New York (2,187), California (1,892), and Florida (1,053) have reported the most cases. So far, no monkeypox deaths have been reported in the United States.
The numbers are increasing, with 1,391 cases reported in the United States on Aug. 12 alone, by far the most in 1 day since the current outbreak began.
“We are still operating under a containment goal, although I know many states are starting to wonder if we’re shifting to more of a mitigation phase right now, given that our case counts are still rising rapidly,” Jennifer McQuiston, DVM, the CDC’s top monkeypox official, told a group of the agency’s advisers on Aug. 9, according to CBS News.
Since late July, the United States has reported more monkeypox cases than any other nation. After the United States, Spain has reported 5,162 cases, the United Kingdom 3,017, and France 2,423, according to the World Health Organization.
Globally, 31,655 cases have been recorded, with 5,108 of those cases coming in the last 7 days, according to the WHO. There have been 12 deaths attributed to monkeypox, with one coming in the last week.
The smallpox-like disease was first found in humans in the Democratic Republic of the Congo in 1970 and has become more common in West and Central Africa. It began spreading to European and other Western nations in May 2022.
The WHO declared it a global public health emergency in late July, and the Biden administration declared it a national health emergency Aug. 4.
To fight the spread of monkeypox, the Biden administration is buying $26 million worth of SIGA Technologies Inc.’s IV version of the antiviral drug TPOXX, the company announced on Aug. 9.
U.S. health officials also modified monkeypox vaccine dosing instructions to stretch the supply of vaccine. Instead of sticking with a standard shot that would enter deep into tissue, the FDA now encourages a new way: just under the skin at one-fifth the usual dose.
A version of this article first appeared on WebMD.com.
FDA approves Enhertu (trastuzumab deruxtecan) for HER2 lung cancer
Patients with lung cancer now have another treatment option: If their tumors are found to carry HER2 mutations, they can now be treated with trastuzumab deruxtecan (Enhertu), a drug that specifically targets that defect.
This product is already approved for used in HER2-positive breast cancer and gastric cancer. 
The FDA also approved companion diagnostic tests to detect HER2 mutations: Life Technologies Corporation’s Oncomine Dx Target Test for use in lung tissue and Guardant Health’s Guardant360 CDx for use on plasma samples. The agency notes that if no mutation is detected in a plasma specimen, the tumor tissue should be tested.
Specifically, the new indication is used in patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have already received a prior systemic therapy.
About 3% of nonsquamous NSCLC tumors carry mutations in the HER2 gene, and they are associated with female sex, never-smokers, and a poor prognosis.
“HER2 mutant non–small cell lung cancer is an aggressive form of disease, which commonly affects young patients who have faced limited treatment options and a poor prognosis to date,” said Dave Fredrickson, executive vice-president of the oncology business unit at AstraZeneca.
The new approval “provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease,” he commented in a company press release.
This is an accelerated approval, based on overall response rate data from the DESTINY-Lung02 phase 2 trial, the company noted. An interim efficacy analysis in a prespecified patient cohort showed that trastuzumab deruxtecan (at 5.4 mg/kg) demonstrated a confirmed overall response rate of 57.7% (n = 52; 95% confidence interval, 43.2%-71.3%) in patients with HER2-mutant unresectable or metastatic nonsquamous NSCLC who had received one prior systemic therapy as assessed by blinded independent central review. Complete responses were seen in 1.9% of patients (n = 1) and partial responses in 55.8% of patients (n = 29), with a median duration of response of 8.7 months (95% CI, 7.1-NE).
The FDA noted that for the 52 patients in the primary efficacy population of the DESTINY-Lung02 trial, the median age was 58 years (range, 30-78 years); 69% were female; and 79% were Asian, 12% were White, and 10% were of other races.
Clinical data welcomed by experts
Clinical data are already available from the DESTINY-Lung 01 trial, and the results were welcomed enthusiastically by experts when they were published in the New England Journal of Medicine earlier this year.
“These results establish the new standard of care for patients with NSCLC harboring HER2 mutations,” Antonio Passaro, MD, PhD, from the European Institute of Oncology IRCCS, Milan, and Solange Peters, MD, PhD, from Lausanne (Switzerland) University Hospital, wrote in an accompanying editorial.
This trial involved 91 patients, all treated with trastuzumab deruxtecan (at 6.4 mg/kg of body weight every 3 weeks). The median duration of treatment was 6.9 months, and the median follow-up was 13.1 months.
The results showed a 55% centrally confirmed objective response, and median duration of response was 9.3 months.
In addition, the investigators reported a median progression-free survival of 8.2 months and a median overall survival of almost 18 months, both of which they described as “encouraging” in this patient population.
However, the results also highlighted a problem with the drug in this patient population. Notably, 26% of patients experienced interstitial lung disease, which resulted in death in two patients. The drug was also withdrawn in 16 patients and interrupted in 8 patients because of this adverse event.
Editorialists Dr. Passaro and Dr. Peters described this finding as “a concern” and note that “the incidence of interstitial lung disease is significantly higher among patients with lung cancer than among those with breast or gastric cancers, which may indicate a role of smoking-related damage.”
They also highlighted the need for an “investigation of the clinical efficacy of a reduced dose of trastuzumab deruxtecan,” and so the dose was reduced for the DESTINY-Lung02 trial.
A version of this article first appeared on Medscape.com.
Patients with lung cancer now have another treatment option: If their tumors are found to carry HER2 mutations, they can now be treated with trastuzumab deruxtecan (Enhertu), a drug that specifically targets that defect.
This product is already approved for used in HER2-positive breast cancer and gastric cancer.
The FDA also approved companion diagnostic tests to detect HER2 mutations: Life Technologies Corporation’s Oncomine Dx Target Test for use in lung tissue and Guardant Health’s Guardant360 CDx for use on plasma samples. The agency notes that if no mutation is detected in a plasma specimen, the tumor tissue should be tested.
Specifically, the new indication is used in patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have already received a prior systemic therapy.
About 3% of nonsquamous NSCLC tumors carry mutations in the HER2 gene, and they are associated with female sex, never-smokers, and a poor prognosis.
“HER2 mutant non–small cell lung cancer is an aggressive form of disease, which commonly affects young patients who have faced limited treatment options and a poor prognosis to date,” said Dave Fredrickson, executive vice-president of the oncology business unit at AstraZeneca.
The new approval “provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease,” he commented in a company press release.
This is an accelerated approval, based on overall response rate data from the DESTINY-Lung02 phase 2 trial, the company noted. An interim efficacy analysis in a prespecified patient cohort showed that trastuzumab deruxtecan (at 5.4 mg/kg) demonstrated a confirmed overall response rate of 57.7% (n = 52; 95% confidence interval, 43.2%-71.3%) in patients with HER2-mutant unresectable or metastatic nonsquamous NSCLC who had received one prior systemic therapy as assessed by blinded independent central review. Complete responses were seen in 1.9% of patients (n = 1) and partial responses in 55.8% of patients (n = 29), with a median duration of response of 8.7 months (95% CI, 7.1-NE).
The FDA noted that for the 52 patients in the primary efficacy population of the DESTINY-Lung02 trial, the median age was 58 years (range, 30-78 years); 69% were female; and 79% were Asian, 12% were White, and 10% were of other races.
Clinical data welcomed by experts
Clinical data are already available from the DESTINY-Lung 01 trial, and the results were welcomed enthusiastically by experts when they were published in the New England Journal of Medicine earlier this year.
“These results establish the new standard of care for patients with NSCLC harboring HER2 mutations,” Antonio Passaro, MD, PhD, from the European Institute of Oncology IRCCS, Milan, and Solange Peters, MD, PhD, from Lausanne (Switzerland) University Hospital, wrote in an accompanying editorial.
This trial involved 91 patients, all treated with trastuzumab deruxtecan (at 6.4 mg/kg of body weight every 3 weeks). The median duration of treatment was 6.9 months, and the median follow-up was 13.1 months.
The results showed a 55% centrally confirmed objective response, and median duration of response was 9.3 months.
In addition, the investigators reported a median progression-free survival of 8.2 months and a median overall survival of almost 18 months, both of which they described as “encouraging” in this patient population.
However, the results also highlighted a problem with the drug in this patient population. Notably, 26% of patients experienced interstitial lung disease, which resulted in death in two patients. The drug was also withdrawn in 16 patients and interrupted in 8 patients because of this adverse event.
Editorialists Dr. Passaro and Dr. Peters described this finding as “a concern” and note that “the incidence of interstitial lung disease is significantly higher among patients with lung cancer than among those with breast or gastric cancers, which may indicate a role of smoking-related damage.”
They also highlighted the need for an “investigation of the clinical efficacy of a reduced dose of trastuzumab deruxtecan,” and so the dose was reduced for the DESTINY-Lung02 trial.
A version of this article first appeared on Medscape.com.
Patients with lung cancer now have another treatment option: If their tumors are found to carry HER2 mutations, they can now be treated with trastuzumab deruxtecan (Enhertu), a drug that specifically targets that defect.
This product is already approved for used in HER2-positive breast cancer and gastric cancer.
The FDA also approved companion diagnostic tests to detect HER2 mutations: Life Technologies Corporation’s Oncomine Dx Target Test for use in lung tissue and Guardant Health’s Guardant360 CDx for use on plasma samples. The agency notes that if no mutation is detected in a plasma specimen, the tumor tissue should be tested.
Specifically, the new indication is used in patients with unresectable or metastatic non–small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have already received a prior systemic therapy.
About 3% of nonsquamous NSCLC tumors carry mutations in the HER2 gene, and they are associated with female sex, never-smokers, and a poor prognosis.
“HER2 mutant non–small cell lung cancer is an aggressive form of disease, which commonly affects young patients who have faced limited treatment options and a poor prognosis to date,” said Dave Fredrickson, executive vice-president of the oncology business unit at AstraZeneca.
The new approval “provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease,” he commented in a company press release.
This is an accelerated approval, based on overall response rate data from the DESTINY-Lung02 phase 2 trial, the company noted. An interim efficacy analysis in a prespecified patient cohort showed that trastuzumab deruxtecan (at 5.4 mg/kg) demonstrated a confirmed overall response rate of 57.7% (n = 52; 95% confidence interval, 43.2%-71.3%) in patients with HER2-mutant unresectable or metastatic nonsquamous NSCLC who had received one prior systemic therapy as assessed by blinded independent central review. Complete responses were seen in 1.9% of patients (n = 1) and partial responses in 55.8% of patients (n = 29), with a median duration of response of 8.7 months (95% CI, 7.1-NE).
The FDA noted that for the 52 patients in the primary efficacy population of the DESTINY-Lung02 trial, the median age was 58 years (range, 30-78 years); 69% were female; and 79% were Asian, 12% were White, and 10% were of other races.
Clinical data welcomed by experts
Clinical data are already available from the DESTINY-Lung 01 trial, and the results were welcomed enthusiastically by experts when they were published in the New England Journal of Medicine earlier this year.
“These results establish the new standard of care for patients with NSCLC harboring HER2 mutations,” Antonio Passaro, MD, PhD, from the European Institute of Oncology IRCCS, Milan, and Solange Peters, MD, PhD, from Lausanne (Switzerland) University Hospital, wrote in an accompanying editorial.
This trial involved 91 patients, all treated with trastuzumab deruxtecan (at 6.4 mg/kg of body weight every 3 weeks). The median duration of treatment was 6.9 months, and the median follow-up was 13.1 months.
The results showed a 55% centrally confirmed objective response, and median duration of response was 9.3 months.
In addition, the investigators reported a median progression-free survival of 8.2 months and a median overall survival of almost 18 months, both of which they described as “encouraging” in this patient population.
However, the results also highlighted a problem with the drug in this patient population. Notably, 26% of patients experienced interstitial lung disease, which resulted in death in two patients. The drug was also withdrawn in 16 patients and interrupted in 8 patients because of this adverse event.
Editorialists Dr. Passaro and Dr. Peters described this finding as “a concern” and note that “the incidence of interstitial lung disease is significantly higher among patients with lung cancer than among those with breast or gastric cancers, which may indicate a role of smoking-related damage.”
They also highlighted the need for an “investigation of the clinical efficacy of a reduced dose of trastuzumab deruxtecan,” and so the dose was reduced for the DESTINY-Lung02 trial.
A version of this article first appeared on Medscape.com.
FDA authorizes intradermal use of Jynneos vaccine for monkeypox
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Aug. 9 authorized intradermal administration of the Jynneos vaccine for the treatment of monkeypox. The process, approved specifically for high-risk patients, was passed under the administration’s Emergency Use Authorization. It follows the decision on Aug. 4 by the U.S. Department of Health and Human Services to declare monkeypox a public health emergency. Intradermal administration will allow providers to get five doses out of a one-dose vial.
This news organization will update this article as more information becomes available.
A version of this article first appeared on Medscape.com.
Children and COVID: Severe illness rising as vaccination effort stalls
, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.
The deceleration in new cases, however, does not apply to emergency department visits and hospital admissions. The proportion of ED visits with diagnosed COVID rose steadily throughout June and July, as 7-day averages went from 2.6% on June 1 to 6.3% on July 31 for children aged 0-11 years, from 2.1% to 3.1% for children aged 12-15, and from 2.4% to 3.5% for 16- to 17-year-olds, according to data from the Centers for Disease Control and Prevention.
The rate of new admissions with confirmed COVID, which reached 0.46 per 100,000 population for children aged 0-17 years on July 30, has more than tripled since early April, when it had fallen to 0.13 per 100,000 in the wake of the Omicron surge, the CDC reported on its COVID Data Tracker.
A smaller but more detailed sample of children from the COVID-19–Associated Hospitalization Network (COVID-NET), which covers nearly 100 counties in 14 states, indicates that the increase in new admissions is occurring almost entirely among children aged 0-4 years, who had a rate of 5.6 per 100,000 for the week of July 17-23, compared with 0.8 per 100,000 for 5- to 11-year-olds and 1.5 per 100,000 for those aged 12-17, the CDC said.
Vaccine’s summer rollout gets lukewarm reception
As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.
That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.
, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.
The deceleration in new cases, however, does not apply to emergency department visits and hospital admissions. The proportion of ED visits with diagnosed COVID rose steadily throughout June and July, as 7-day averages went from 2.6% on June 1 to 6.3% on July 31 for children aged 0-11 years, from 2.1% to 3.1% for children aged 12-15, and from 2.4% to 3.5% for 16- to 17-year-olds, according to data from the Centers for Disease Control and Prevention.
The rate of new admissions with confirmed COVID, which reached 0.46 per 100,000 population for children aged 0-17 years on July 30, has more than tripled since early April, when it had fallen to 0.13 per 100,000 in the wake of the Omicron surge, the CDC reported on its COVID Data Tracker.
A smaller but more detailed sample of children from the COVID-19–Associated Hospitalization Network (COVID-NET), which covers nearly 100 counties in 14 states, indicates that the increase in new admissions is occurring almost entirely among children aged 0-4 years, who had a rate of 5.6 per 100,000 for the week of July 17-23, compared with 0.8 per 100,000 for 5- to 11-year-olds and 1.5 per 100,000 for those aged 12-17, the CDC said.
Vaccine’s summer rollout gets lukewarm reception
As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.
That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.
, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
After new child cases jumped by 22% during the week of July 15-21, the two successive weeks have produced increases of 3.9% (July 22-29) and 1.2% (July 30-Aug. 4). The latest weekly count from all states and territories still reporting was 96,599, the AAP and CHA said in their weekly COVID report, noting that several states have stopped reporting child cases and that others are reporting every other week.
The deceleration in new cases, however, does not apply to emergency department visits and hospital admissions. The proportion of ED visits with diagnosed COVID rose steadily throughout June and July, as 7-day averages went from 2.6% on June 1 to 6.3% on July 31 for children aged 0-11 years, from 2.1% to 3.1% for children aged 12-15, and from 2.4% to 3.5% for 16- to 17-year-olds, according to data from the Centers for Disease Control and Prevention.
The rate of new admissions with confirmed COVID, which reached 0.46 per 100,000 population for children aged 0-17 years on July 30, has more than tripled since early April, when it had fallen to 0.13 per 100,000 in the wake of the Omicron surge, the CDC reported on its COVID Data Tracker.
A smaller but more detailed sample of children from the COVID-19–Associated Hospitalization Network (COVID-NET), which covers nearly 100 counties in 14 states, indicates that the increase in new admissions is occurring almost entirely among children aged 0-4 years, who had a rate of 5.6 per 100,000 for the week of July 17-23, compared with 0.8 per 100,000 for 5- to 11-year-olds and 1.5 per 100,000 for those aged 12-17, the CDC said.
Vaccine’s summer rollout gets lukewarm reception
As a group, children aged 0-4 years have not exactly flocked to the COVID-19 vaccine. As of Aug. 2 – about 6 weeks since the vaccine was authorized for children aged 6 months to 4 years – just 3.8% of those eligible had received at least one dose. Among children aged 5-11 the corresponding number on Aug. 2 was 37.4%, and for those aged 12-17 years it was 70.3%, the CDC data show.
That 3.8% of children aged less than 5 years represents almost 756,000 initial doses. That compares with over 6 million children aged 5-11 years who had received at least one dose through the first 6 weeks of their vaccination experience and over 5 million children aged 12-15, according to the COVID Data Tracker.