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FDA approves ribociclib for HR+, HER2– advanced breast cancer
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
[email protected]
On Twitter @NikolaidesLaura
FDA approves nivolumab for advanced urothelial carcinoma
The Food and Drug Administration has granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
Approval was based on objective response rate (ORR) in a single-arm study of 270 patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients received nivolumab, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The ORR was 19.6% (53/270; 95% confidence interval, 15.1-24.9), according to a written statement from the FDA.
Fourteen patients died from causes other than disease progression, including four who died from pneumonitis or cardiovascular failure attributed to nivolumab, the FDA said.
The most common adverse reactions were fatigue, musculoskeletal pain, nausea, and decreased appetite. Adverse reactions led to dose discontinuation in 17% of patients.
The recommended dose and schedule for nivolumab for the above indication is 240 mg intravenously every 2 weeks.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, melanoma, and squamous cell carcinoma of the head and neck.
The Food and Drug Administration has granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
Approval was based on objective response rate (ORR) in a single-arm study of 270 patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients received nivolumab, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The ORR was 19.6% (53/270; 95% confidence interval, 15.1-24.9), according to a written statement from the FDA.
Fourteen patients died from causes other than disease progression, including four who died from pneumonitis or cardiovascular failure attributed to nivolumab, the FDA said.
The most common adverse reactions were fatigue, musculoskeletal pain, nausea, and decreased appetite. Adverse reactions led to dose discontinuation in 17% of patients.
The recommended dose and schedule for nivolumab for the above indication is 240 mg intravenously every 2 weeks.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, melanoma, and squamous cell carcinoma of the head and neck.
The Food and Drug Administration has granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
Approval was based on objective response rate (ORR) in a single-arm study of 270 patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients received nivolumab, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The ORR was 19.6% (53/270; 95% confidence interval, 15.1-24.9), according to a written statement from the FDA.
Fourteen patients died from causes other than disease progression, including four who died from pneumonitis or cardiovascular failure attributed to nivolumab, the FDA said.
The most common adverse reactions were fatigue, musculoskeletal pain, nausea, and decreased appetite. Adverse reactions led to dose discontinuation in 17% of patients.
The recommended dose and schedule for nivolumab for the above indication is 240 mg intravenously every 2 weeks.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, melanoma, and squamous cell carcinoma of the head and neck.
FDA approves rucaparib for BRCA-positive advanced ovarian cancer
The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.
Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement.
All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website.
Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.
Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement.
All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website.
Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has granted accelerated approval to rucaparib for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a germline or somatic BRCA gene mutation. The FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with rucaparib to detect BRCA1 and BRCA2 gene mutations in the tumor tissue.
Approval of rucaparib (Rubraca), a poly ADP-ribose polymerase (PARP) inhibitor, was based on an objective response rate (ORR) of 54%, and a median duration of response of 9.2 months, in a pooled analysis of two, single-arm clinical trials, the FDA said in a statement.
All 106 patients in the two trials had BRCA-mutated advanced ovarian cancer and had been treated with two or more chemotherapy regimens. They received rucaparib 600 mg orally twice daily. BRCA gene mutations were confirmed in 96% of participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of rucaparib should be discontinued if MDS/AML is confirmed, the FDA said on its website.
Rucaparib is marketed by Clovis Oncology. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine.
[email protected]
On Twitter @nikolaideslaura
FDA affirms bladder cancer warning with diabetes drug
Though a 10-year epidemiologic study did not find an increased risk of bladder cancer with pioglitazone use, the Food and Drug Administration has chosen to affirm the warning on the label of the type 2 diabetes drug following an updated review of several studies.
The FDA issued a warning about the possible risk of bladder cancer based on interim results from the 10-year epidemiologic study in 2010, and it changed the labels of pioglitazone-containing medicines in 2011 to include warnings about this risk.
There was a modest trend toward higher risk with increasing duration of use, but the trend was not statistically significant. Compared with the interim 5-year results, these final 10-year results found weaker associations that were not statistically significant.
The directions of the associations, however, remained unchanged. Based on these findings and other reviewed studies with conflicting results, the FDA has concluded that use of pioglitazone may be linked to an increased risk of bladder cancer.
The labels of pioglitazone-containing medicines already contain warnings about this risk, but the FDA has now approved label updates to describe the additional studies reviewed.
Read the FDA update and data summary here.
[email protected]
On Twitter @nikolaideslaura
Though a 10-year epidemiologic study did not find an increased risk of bladder cancer with pioglitazone use, the Food and Drug Administration has chosen to affirm the warning on the label of the type 2 diabetes drug following an updated review of several studies.
The FDA issued a warning about the possible risk of bladder cancer based on interim results from the 10-year epidemiologic study in 2010, and it changed the labels of pioglitazone-containing medicines in 2011 to include warnings about this risk.
There was a modest trend toward higher risk with increasing duration of use, but the trend was not statistically significant. Compared with the interim 5-year results, these final 10-year results found weaker associations that were not statistically significant.
The directions of the associations, however, remained unchanged. Based on these findings and other reviewed studies with conflicting results, the FDA has concluded that use of pioglitazone may be linked to an increased risk of bladder cancer.
The labels of pioglitazone-containing medicines already contain warnings about this risk, but the FDA has now approved label updates to describe the additional studies reviewed.
Read the FDA update and data summary here.
[email protected]
On Twitter @nikolaideslaura
Though a 10-year epidemiologic study did not find an increased risk of bladder cancer with pioglitazone use, the Food and Drug Administration has chosen to affirm the warning on the label of the type 2 diabetes drug following an updated review of several studies.
The FDA issued a warning about the possible risk of bladder cancer based on interim results from the 10-year epidemiologic study in 2010, and it changed the labels of pioglitazone-containing medicines in 2011 to include warnings about this risk.
There was a modest trend toward higher risk with increasing duration of use, but the trend was not statistically significant. Compared with the interim 5-year results, these final 10-year results found weaker associations that were not statistically significant.
The directions of the associations, however, remained unchanged. Based on these findings and other reviewed studies with conflicting results, the FDA has concluded that use of pioglitazone may be linked to an increased risk of bladder cancer.
The labels of pioglitazone-containing medicines already contain warnings about this risk, but the FDA has now approved label updates to describe the additional studies reviewed.
Read the FDA update and data summary here.
[email protected]
On Twitter @nikolaideslaura
FDA approves daratumumab in combination with standard therapy for multiple myeloma
The Food and Drug Administration has approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
The drug was approved last year as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.
In the POLLUX trial, median PFS had not been reached in the daratumumab plus lenalidomide and dexamethasone arm and was 18.4 months among patients getting lenalidomide and dexamethasone alone (HR=0.37; 95% CI: 0.27, 0.52; P less than.0001).
In the CASTOR trial, which compared the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone, the estimated median PFS had not been reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio, 0.39; 95% confidence interval, 0.28-0.53; P less than .0001).
Updated results for both trials will be presented at the upcoming annual meeting of the American Society of Hematology (abstract #1150, abstract #1151).
The most frequently reported adverse reactions in POLLUX were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough, and dyspnea. The most frequently reported adverse reactions in CASTOR were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory neuropathy, cough, and dyspnea.
The recommended dose of daratumumab is 16 mg/kg IV (calculated on actual body weight), the FDA said.
Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
The drug was approved last year as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.
In the POLLUX trial, median PFS had not been reached in the daratumumab plus lenalidomide and dexamethasone arm and was 18.4 months among patients getting lenalidomide and dexamethasone alone (HR=0.37; 95% CI: 0.27, 0.52; P less than.0001).
In the CASTOR trial, which compared the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone, the estimated median PFS had not been reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio, 0.39; 95% confidence interval, 0.28-0.53; P less than .0001).
Updated results for both trials will be presented at the upcoming annual meeting of the American Society of Hematology (abstract #1150, abstract #1151).
The most frequently reported adverse reactions in POLLUX were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough, and dyspnea. The most frequently reported adverse reactions in CASTOR were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory neuropathy, cough, and dyspnea.
The recommended dose of daratumumab is 16 mg/kg IV (calculated on actual body weight), the FDA said.
Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
The drug was approved last year as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent.
In the POLLUX trial, median PFS had not been reached in the daratumumab plus lenalidomide and dexamethasone arm and was 18.4 months among patients getting lenalidomide and dexamethasone alone (HR=0.37; 95% CI: 0.27, 0.52; P less than.0001).
In the CASTOR trial, which compared the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone, the estimated median PFS had not been reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio, 0.39; 95% confidence interval, 0.28-0.53; P less than .0001).
Updated results for both trials will be presented at the upcoming annual meeting of the American Society of Hematology (abstract #1150, abstract #1151).
The most frequently reported adverse reactions in POLLUX were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough, and dyspnea. The most frequently reported adverse reactions in CASTOR were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory neuropathy, cough, and dyspnea.
The recommended dose of daratumumab is 16 mg/kg IV (calculated on actual body weight), the FDA said.
Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
FDA approves nivolumab for advanced squamous cell carcinoma of the head and neck
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved the immune checkpoint inhibitor nivolumab for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
The FDA based its approval on an improvement in overall survival demonstrated in CheckMate-141, a randomized trial comparing nivolumab with the investigator’s choice of standard therapy, the FDA said in a written statement.
Earlier this year, the FDA granted accelerated approval to another checkpoint inhibitor targeting the PD-1/PD-L1 pathway, pembrolizumab, for the same indication, based on an objective response rate of 16% in the nonrandomized KEYNOTE-012 trial. Merck Sharp & Dohme, maker of pembrolizumab, is looking to demonstrate an improvement in overall survival with the ongoing KEYNOTE-040 study.
Checkmate-141 enrolled 361 patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy and randomized (2:1) to nivolumab 3 mg/kg every 2 weeks intravenously or the investigator’s choice of cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly; methotrexate 40 mg/m2 IV weekly; or docetaxel 30 mg/m2 IV weekly until disease progression or unacceptable toxicity.
As reported at the European Society of Medical Oncology Congress and in the New England Journal of Medicine (2016;375:1856-67), the median overall survival was 7.5 months for patients on nivolumab, compared with 5.1 months for those on standard chemotherapy. The hazard ratio for death with nivolumab was 0.70 (P = .01). Estimates of 1-year survival were 36% vs. 16.6%, respectively.
Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of patients on nivolumab, compared with 35.1% of those on standard therapy. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.
The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than with standard therapy were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than with standard therapy were increased alkaline phosphatase level, increased amylase level, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone level, the FDA said.
Nivolumab is marketed as Opdivo by Bristol-Myers Squibb and previously has been approved to treat classical Hodgkin’s lymphoma, advanced renal cell carcinoma, lung cancer, and melanoma.
[email protected]
On Twitter @NikolaidesLaura
FDA expands indication for pembrolizumab in NSCLC
The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.
Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.
The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).
In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.
The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.
The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.
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On Twitter @nikolaideslaura
The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.
Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.
The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).
In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.
The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.
The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved pembrolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first approval of a checkpoint inhibitor for first-line treatment of the disease.
Pembrolizumab (Keytruda) is now approved to treat patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC, the FDA said in a written statement.
The FDA based its approval on improvement in overall survival in two trials comparing treatment with pembrolizumab to treatment from chemotherapy. In one trial of 305 patients who had no prior treatment for metastatic NSCLC and TPS greater than or equal to 50%, those who received pembrolizumab (200 mg every 3 weeks) had a statistically significant improvement in overall survival, compared with patients randomized to receive chemotherapy (hazard ratio, 0.60; 95% confidence interval, 0.41-0.89; P less than .005). There was also significant improvement in progression-free survival for those receiving the checkpoint inhibitor (HR, 0.50; 95% CI, 0.37-0.68; P less than .001).
In the second trial, a three-arm trial of 1,033 patients who were previously treated for metastatic NSCLC with a TPS greater than or equal to 1%, those randomized to pembrolizumab 2 mg/kg every 3 weeks (HR, 0.71; 95% CI, 0.58-0.88; P less than .001) or pembrolizumab 10 mg/kg every 3 weeks (HR, 0.61; 95% CI, 0.49-0.75; P less than .001) had an improved overall survival, compared with patients receiving docetaxel. The median survival was 10.4 months in the pembrolizumab 2 mg/kg arm, 12.7 months in the pembrolizumab 10 mg/kg arm, and 8.5 months in the docetaxel arm.
The most common side effects of treatment with pembrolizumab included decreased appetite, fatigue, nausea, dyspnea, cough, and constipation. Rare but serious adverse events included immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, the FDA said.
The recommended dose and schedule of pembrolizumab for NSCLC is 200 mg intravenously every 3 weeks. Full prescribing information is available here.
[email protected]
On Twitter @nikolaideslaura
FDA approves atezolizumab for advanced NSCLC
The Food and Drug Administration has approved the programmed death-ligand 1 (PD-L1) blocking antibody atezolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed during or following platinum-containing chemotherapy.
The FDA previously approved atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
Approval for treatment of NSCLC was based on results from the phase III OAK and phase II POPLAR trials that enrolled a total of 1,137 patients with NSCLC whose disease had progressed on platinum-containing chemotherapy. In OAK, median overall survival for patients assigned to atezolizumab was 13.8 months, compared with 9.6 months for patients assigned to docetaxel, as recently reported at the European Society for Medical Oncology Congress.
In POPLAR, overall survival was 12.6 months for patients receiving atezolizumab versus 9.7 months for those assigned to docetaxel, as reported at the European Cancer Congress in 2015.
The most common (greater than or equal to 20%) adverse reactions in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation, according to the FDA website. The most common (greater than or equal to 2%) grade 3-4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab have included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
Patients with EGFR or ALK genomic tumor aberrations should not receive atezolizumab before having disease progression on FDA-approved therapy for these aberrations, the FDA said.
Full prescribing information is available on the FDA website.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved the programmed death-ligand 1 (PD-L1) blocking antibody atezolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed during or following platinum-containing chemotherapy.
The FDA previously approved atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
Approval for treatment of NSCLC was based on results from the phase III OAK and phase II POPLAR trials that enrolled a total of 1,137 patients with NSCLC whose disease had progressed on platinum-containing chemotherapy. In OAK, median overall survival for patients assigned to atezolizumab was 13.8 months, compared with 9.6 months for patients assigned to docetaxel, as recently reported at the European Society for Medical Oncology Congress.
In POPLAR, overall survival was 12.6 months for patients receiving atezolizumab versus 9.7 months for those assigned to docetaxel, as reported at the European Cancer Congress in 2015.
The most common (greater than or equal to 20%) adverse reactions in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation, according to the FDA website. The most common (greater than or equal to 2%) grade 3-4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab have included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
Patients with EGFR or ALK genomic tumor aberrations should not receive atezolizumab before having disease progression on FDA-approved therapy for these aberrations, the FDA said.
Full prescribing information is available on the FDA website.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has approved the programmed death-ligand 1 (PD-L1) blocking antibody atezolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed during or following platinum-containing chemotherapy.
The FDA previously approved atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
Approval for treatment of NSCLC was based on results from the phase III OAK and phase II POPLAR trials that enrolled a total of 1,137 patients with NSCLC whose disease had progressed on platinum-containing chemotherapy. In OAK, median overall survival for patients assigned to atezolizumab was 13.8 months, compared with 9.6 months for patients assigned to docetaxel, as recently reported at the European Society for Medical Oncology Congress.
In POPLAR, overall survival was 12.6 months for patients receiving atezolizumab versus 9.7 months for those assigned to docetaxel, as reported at the European Cancer Congress in 2015.
The most common (greater than or equal to 20%) adverse reactions in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation, according to the FDA website. The most common (greater than or equal to 2%) grade 3-4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab have included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
Patients with EGFR or ALK genomic tumor aberrations should not receive atezolizumab before having disease progression on FDA-approved therapy for these aberrations, the FDA said.
Full prescribing information is available on the FDA website.
[email protected]
On Twitter @nikolaideslaura
FDA grants accelerated approval to olaratumab for soft tissue sarcoma
The Food and Drug Administration has granted accelerated approval to olaratumab with doxorubicin for the treatment of adult patients with certain types of soft tissue sarcoma.
“This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago,” Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research and acting director of the FDA Oncology Center of Excellence, said in a statement.
Approval was based on a statistically significant improvement in survival in a randomized trial involving 133 patients with more than 25 different subtypes of metastatic soft tissue sarcoma. Patients received olaratumab (Lartruvo) with doxorubicin or doxorubicin alone. Median survival was 26.5 months for patients who received both drugs, compared with 14.7 months for patients who received doxorubicin alone. Median progression-free survival was 8.2 months for patients who received both drugs and 4.4 months for patients who received doxorubicin alone.
The most common adverse reactions from olaratumab were nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. There are serious risks of infusion-related reactions and embryo-fetal harm, the FDA warned.
Olaratumab was approved under the FDA’s accelerated approval program after receiving fast track designation, breakthrough therapy designation, and a priority review status. The drug also received an orphan drug designation. Drug maker Eli Lilly is currently conducting a larger study of olaratumab across multiple subtypes of soft tissue sarcoma.
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On Twitter @nikolaideslaura
The Food and Drug Administration has granted accelerated approval to olaratumab with doxorubicin for the treatment of adult patients with certain types of soft tissue sarcoma.
“This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago,” Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research and acting director of the FDA Oncology Center of Excellence, said in a statement.
Approval was based on a statistically significant improvement in survival in a randomized trial involving 133 patients with more than 25 different subtypes of metastatic soft tissue sarcoma. Patients received olaratumab (Lartruvo) with doxorubicin or doxorubicin alone. Median survival was 26.5 months for patients who received both drugs, compared with 14.7 months for patients who received doxorubicin alone. Median progression-free survival was 8.2 months for patients who received both drugs and 4.4 months for patients who received doxorubicin alone.
The most common adverse reactions from olaratumab were nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. There are serious risks of infusion-related reactions and embryo-fetal harm, the FDA warned.
Olaratumab was approved under the FDA’s accelerated approval program after receiving fast track designation, breakthrough therapy designation, and a priority review status. The drug also received an orphan drug designation. Drug maker Eli Lilly is currently conducting a larger study of olaratumab across multiple subtypes of soft tissue sarcoma.
[email protected]
On Twitter @nikolaideslaura
The Food and Drug Administration has granted accelerated approval to olaratumab with doxorubicin for the treatment of adult patients with certain types of soft tissue sarcoma.
“This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago,” Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research and acting director of the FDA Oncology Center of Excellence, said in a statement.
Olaratumab, a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody, is approved for use with doxorubicin for the treatment of patients with soft tissue sarcoma who cannot be cured with radiation or surgery and who have a type of soft tissue sarcoma for which an anthracycline is an appropriate treatment, according to the FDA announcement.
Approval was based on a statistically significant improvement in survival in a randomized trial involving 133 patients with more than 25 different subtypes of metastatic soft tissue sarcoma. Patients received olaratumab (Lartruvo) with doxorubicin or doxorubicin alone. Median survival was 26.5 months for patients who received both drugs, compared with 14.7 months for patients who received doxorubicin alone. Median progression-free survival was 8.2 months for patients who received both drugs and 4.4 months for patients who received doxorubicin alone.
The most common adverse reactions from olaratumab were nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. There are serious risks of infusion-related reactions and embryo-fetal harm, the FDA warned.
Olaratumab was approved under the FDA’s accelerated approval program after receiving fast track designation, breakthrough therapy designation, and a priority review status. The drug also received an orphan drug designation. Drug maker Eli Lilly is currently conducting a larger study of olaratumab across multiple subtypes of soft tissue sarcoma.
[email protected]
On Twitter @nikolaideslaura
FDA grants accelerated approval to pembrolizumab for advanced HNSCC
The Food and Drug Administration has granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Approval was based on an objective response rate of 16% for 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy. These patients, a subgroup of patients in an international, multicenter, nonrandomized, open-label, multicohort study, received intravenous pembrolizumab (Keytruda) 10 mg/kg every 2 weeks or 200 mg every 3 weeks, the FDA said in a written statement.
The median response duration for patients receiving pembrolizumab, a checkpoint inhibitor targeting the PD-1/PD-L1 pathway, had not been reached at the time of analysis. The range for duration of response was 2.4 months to 27.7 months (response ongoing). Among the 28 responding patients, 23 (82%) had responses of 6 months or longer, the FDA said.
The most common adverse reactions observed in 192 patients with HNSCC who received at least one dose of pembrolizumab were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were similar to those occurring in patients with melanoma or NSCLC, with the exception of an increased incidence of facial edema (10% all grades, 2.1% grades 3-4) and new or worsening hypothyroidism (14.6% all grades). The most frequent serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders, the FDA noted.
Merck Sharp & Dohme Corp., maker of pembrolizumab, is required to conduct a multicenter, randomized trial establishing the superiority of pembrolizumab over standard therapy as a condition for accelerated approval and is doing so with the ongoing KEYNOTE 040 study, with a primary endpoint of overall survival.
The FDA-recommended dose and schedule of pembrolizumab for patients with HNSCC and disease progression on or after platinum-containing chemotherapy is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
On Twitter @NikolaidesLaura
The Food and Drug Administration has granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Approval was based on an objective response rate of 16% for 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy. These patients, a subgroup of patients in an international, multicenter, nonrandomized, open-label, multicohort study, received intravenous pembrolizumab (Keytruda) 10 mg/kg every 2 weeks or 200 mg every 3 weeks, the FDA said in a written statement.
The median response duration for patients receiving pembrolizumab, a checkpoint inhibitor targeting the PD-1/PD-L1 pathway, had not been reached at the time of analysis. The range for duration of response was 2.4 months to 27.7 months (response ongoing). Among the 28 responding patients, 23 (82%) had responses of 6 months or longer, the FDA said.
The most common adverse reactions observed in 192 patients with HNSCC who received at least one dose of pembrolizumab were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were similar to those occurring in patients with melanoma or NSCLC, with the exception of an increased incidence of facial edema (10% all grades, 2.1% grades 3-4) and new or worsening hypothyroidism (14.6% all grades). The most frequent serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders, the FDA noted.
Merck Sharp & Dohme Corp., maker of pembrolizumab, is required to conduct a multicenter, randomized trial establishing the superiority of pembrolizumab over standard therapy as a condition for accelerated approval and is doing so with the ongoing KEYNOTE 040 study, with a primary endpoint of overall survival.
The FDA-recommended dose and schedule of pembrolizumab for patients with HNSCC and disease progression on or after platinum-containing chemotherapy is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
On Twitter @NikolaidesLaura
The Food and Drug Administration has granted accelerated approval to pembrolizumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Approval was based on an objective response rate of 16% for 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy. These patients, a subgroup of patients in an international, multicenter, nonrandomized, open-label, multicohort study, received intravenous pembrolizumab (Keytruda) 10 mg/kg every 2 weeks or 200 mg every 3 weeks, the FDA said in a written statement.
The median response duration for patients receiving pembrolizumab, a checkpoint inhibitor targeting the PD-1/PD-L1 pathway, had not been reached at the time of analysis. The range for duration of response was 2.4 months to 27.7 months (response ongoing). Among the 28 responding patients, 23 (82%) had responses of 6 months or longer, the FDA said.
The most common adverse reactions observed in 192 patients with HNSCC who received at least one dose of pembrolizumab were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were similar to those occurring in patients with melanoma or NSCLC, with the exception of an increased incidence of facial edema (10% all grades, 2.1% grades 3-4) and new or worsening hypothyroidism (14.6% all grades). The most frequent serious adverse reactions were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders, the FDA noted.
Merck Sharp & Dohme Corp., maker of pembrolizumab, is required to conduct a multicenter, randomized trial establishing the superiority of pembrolizumab over standard therapy as a condition for accelerated approval and is doing so with the ongoing KEYNOTE 040 study, with a primary endpoint of overall survival.
The FDA-recommended dose and schedule of pembrolizumab for patients with HNSCC and disease progression on or after platinum-containing chemotherapy is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
On Twitter @NikolaidesLaura
