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FDA approves first treatment for advanced epithelioid sarcoma
The Food and Drug Administration has granted accelerated approval to tazemetostat (Tazverik) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Approval was based on overall response rate in a trial enrolling 62 patients with metastatic or locally advanced epithelioid sarcoma. The overall response rate was 15%, with 1.6% of patients having a complete response and 13% having a partial response. Of the nine patients that had a response, six (67%) had a response lasting 6 months or longer, the FDA said in a press statement.
The most common side effects for patients taking tazemetostat were pain, fatigue, nausea, decreased appetite, vomiting, and constipation. Patients treated with tazemetostat are at increased risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.
“Epithelioid sarcoma accounts for less than 1% of all soft-tissue sarcomas,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research. “Until today, there were no treatment options specifically for patients with epithelioid sarcoma. The approval of Tazverik provides a treatment option that specifically targets this disease.”
Tazemetostat must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks, the FDA said.
The Food and Drug Administration has granted accelerated approval to tazemetostat (Tazverik) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Approval was based on overall response rate in a trial enrolling 62 patients with metastatic or locally advanced epithelioid sarcoma. The overall response rate was 15%, with 1.6% of patients having a complete response and 13% having a partial response. Of the nine patients that had a response, six (67%) had a response lasting 6 months or longer, the FDA said in a press statement.
The most common side effects for patients taking tazemetostat were pain, fatigue, nausea, decreased appetite, vomiting, and constipation. Patients treated with tazemetostat are at increased risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.
“Epithelioid sarcoma accounts for less than 1% of all soft-tissue sarcomas,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research. “Until today, there were no treatment options specifically for patients with epithelioid sarcoma. The approval of Tazverik provides a treatment option that specifically targets this disease.”
Tazemetostat must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks, the FDA said.
The Food and Drug Administration has granted accelerated approval to tazemetostat (Tazverik) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Approval was based on overall response rate in a trial enrolling 62 patients with metastatic or locally advanced epithelioid sarcoma. The overall response rate was 15%, with 1.6% of patients having a complete response and 13% having a partial response. Of the nine patients that had a response, six (67%) had a response lasting 6 months or longer, the FDA said in a press statement.
The most common side effects for patients taking tazemetostat were pain, fatigue, nausea, decreased appetite, vomiting, and constipation. Patients treated with tazemetostat are at increased risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.
“Epithelioid sarcoma accounts for less than 1% of all soft-tissue sarcomas,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the Center for Drug Evaluation and Research. “Until today, there were no treatment options specifically for patients with epithelioid sarcoma. The approval of Tazverik provides a treatment option that specifically targets this disease.”
Tazemetostat must be dispensed with a patient medication guide that describes important information about the drug’s uses and risks, the FDA said.
FDA approves pembrolizumab for BCG-unresponsive NMIBC with CIS
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy.
The approval was based on response in a single-arm trial of 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors, the FDA said in a statement.
The complete response rate in the 96 patients with high-risk BCG-unresponsive NMIBC with CIS was 41% (95% confidence interval, 31-51) and median response duration was 16.2 months.
The most common adverse reactions in patients who received pembrolizumab in the trial were fatigue, diarrhea, rash, pruritus, musculoskeletal pain, hematuria, cough, arthralgia, nausea, constipation, urinary tract infection, peripheral edema, hypothyroidism, and nasopharyngitis.
The recommended dose is 200 mg every 3 weeks, the FDA said.
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy.
The approval was based on response in a single-arm trial of 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors, the FDA said in a statement.
The complete response rate in the 96 patients with high-risk BCG-unresponsive NMIBC with CIS was 41% (95% confidence interval, 31-51) and median response duration was 16.2 months.
The most common adverse reactions in patients who received pembrolizumab in the trial were fatigue, diarrhea, rash, pruritus, musculoskeletal pain, hematuria, cough, arthralgia, nausea, constipation, urinary tract infection, peripheral edema, hypothyroidism, and nasopharyngitis.
The recommended dose is 200 mg every 3 weeks, the FDA said.
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guérin (BCG)–unresponsive, high-risk, non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, who are ineligible for or have elected not to undergo cystectomy.
The approval was based on response in a single-arm trial of 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors, the FDA said in a statement.
The complete response rate in the 96 patients with high-risk BCG-unresponsive NMIBC with CIS was 41% (95% confidence interval, 31-51) and median response duration was 16.2 months.
The most common adverse reactions in patients who received pembrolizumab in the trial were fatigue, diarrhea, rash, pruritus, musculoskeletal pain, hematuria, cough, arthralgia, nausea, constipation, urinary tract infection, peripheral edema, hypothyroidism, and nasopharyngitis.
The recommended dose is 200 mg every 3 weeks, the FDA said.
FDA approves antibody-drug conjugate for advanced urothelial cancer
The Food and Drug Administration has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer that has previously been treated with a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.
The conjugate was approved based on overall response rate in a trial of 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy, the FDA said in a press statement.
The overall response rate was 44%, with 12% having a complete response and 32% having a partial response. The median duration of response was 7.6 months.
The most common side effects for patients were fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritis, and dry skin. Patients may experience hyperglycemia, and blood sugar levels should be monitored closely in patients receiving enfortumab vedotin-ejfv, the FDA said.
Patients may experience eye disorders, and health care professionals may consider prophylactic artificial tears for dry eyes and referral to an ophthalmologist for any new symptoms related to the eye, the agency said. The FDA also advises telling patients of reproductive age to use effective contraception during treatment, and for a period of time thereafter. Women who are pregnant or breastfeeding should not take the antibody-drug conjugate because it may cause harm to a developing fetus or newborn baby or cause delivery complications.
The Food and Drug Administration has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer that has previously been treated with a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.
The conjugate was approved based on overall response rate in a trial of 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy, the FDA said in a press statement.
The overall response rate was 44%, with 12% having a complete response and 32% having a partial response. The median duration of response was 7.6 months.
The most common side effects for patients were fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritis, and dry skin. Patients may experience hyperglycemia, and blood sugar levels should be monitored closely in patients receiving enfortumab vedotin-ejfv, the FDA said.
Patients may experience eye disorders, and health care professionals may consider prophylactic artificial tears for dry eyes and referral to an ophthalmologist for any new symptoms related to the eye, the agency said. The FDA also advises telling patients of reproductive age to use effective contraception during treatment, and for a period of time thereafter. Women who are pregnant or breastfeeding should not take the antibody-drug conjugate because it may cause harm to a developing fetus or newborn baby or cause delivery complications.
The Food and Drug Administration has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer that has previously been treated with a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.
The conjugate was approved based on overall response rate in a trial of 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy, the FDA said in a press statement.
The overall response rate was 44%, with 12% having a complete response and 32% having a partial response. The median duration of response was 7.6 months.
The most common side effects for patients were fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritis, and dry skin. Patients may experience hyperglycemia, and blood sugar levels should be monitored closely in patients receiving enfortumab vedotin-ejfv, the FDA said.
Patients may experience eye disorders, and health care professionals may consider prophylactic artificial tears for dry eyes and referral to an ophthalmologist for any new symptoms related to the eye, the agency said. The FDA also advises telling patients of reproductive age to use effective contraception during treatment, and for a period of time thereafter. Women who are pregnant or breastfeeding should not take the antibody-drug conjugate because it may cause harm to a developing fetus or newborn baby or cause delivery complications.
FDA expands Xtandi approval to mCSPC
The Food and Drug Administration has approved enzalutamide (Xtandi) for patients with metastatic castration-sensitive prostate cancer (mCSPC).
The drug was previously approved for patients with castration-resistant prostate cancer.
Approval was based on radiographic progression-free survival (rPFS) improvement in ARCHES, a trial of 1,150 patients with mCSPC randomized to receive either enzalutamide or placebo daily. All patients received a gonadotropin-releasing hormone analogue or had a prior bilateral orchiectomy.
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Median rPFS was not reached in the enzalutamide, arm compared with 19.4 months (95% confidence interval, 16.6 to not reached) in the placebo arm (HR 0.39; 95% CI, 0.30-0.50; P less than .0001), the FDA said in a statement.
The most common adverse reactions in enzalutamide-treated patients in ARCHES were hot flush, asthenia/fatigue, hypertension, fractures, and musculoskeletal pain.
The recommended dose is 160 mg (four 40 mg capsules) administered orally once daily with or without food, the FDA said.
lnikolaides@mdedge.com
The Food and Drug Administration has approved enzalutamide (Xtandi) for patients with metastatic castration-sensitive prostate cancer (mCSPC).
The drug was previously approved for patients with castration-resistant prostate cancer.
Approval was based on radiographic progression-free survival (rPFS) improvement in ARCHES, a trial of 1,150 patients with mCSPC randomized to receive either enzalutamide or placebo daily. All patients received a gonadotropin-releasing hormone analogue or had a prior bilateral orchiectomy.
[embed:render:related:node:170302]
Median rPFS was not reached in the enzalutamide, arm compared with 19.4 months (95% confidence interval, 16.6 to not reached) in the placebo arm (HR 0.39; 95% CI, 0.30-0.50; P less than .0001), the FDA said in a statement.
The most common adverse reactions in enzalutamide-treated patients in ARCHES were hot flush, asthenia/fatigue, hypertension, fractures, and musculoskeletal pain.
The recommended dose is 160 mg (four 40 mg capsules) administered orally once daily with or without food, the FDA said.
lnikolaides@mdedge.com
The Food and Drug Administration has approved enzalutamide (Xtandi) for patients with metastatic castration-sensitive prostate cancer (mCSPC).
The drug was previously approved for patients with castration-resistant prostate cancer.
Approval was based on radiographic progression-free survival (rPFS) improvement in ARCHES, a trial of 1,150 patients with mCSPC randomized to receive either enzalutamide or placebo daily. All patients received a gonadotropin-releasing hormone analogue or had a prior bilateral orchiectomy.
[embed:render:related:node:170302]
Median rPFS was not reached in the enzalutamide, arm compared with 19.4 months (95% confidence interval, 16.6 to not reached) in the placebo arm (HR 0.39; 95% CI, 0.30-0.50; P less than .0001), the FDA said in a statement.
The most common adverse reactions in enzalutamide-treated patients in ARCHES were hot flush, asthenia/fatigue, hypertension, fractures, and musculoskeletal pain.
The recommended dose is 160 mg (four 40 mg capsules) administered orally once daily with or without food, the FDA said.
lnikolaides@mdedge.com
FDA approves atezolizumab combo as first line for advanced NSCLC
chemotherapy for first-line treatment of adults with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
Atezolizumab has been previously approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations. The monoclonal antibody is also approved to treat adults with metastatic NSCLC who have disease progression during or following chemotherapy, and for those with extensive-stage SCLC.
The current approval was based on a demonstrated improvement in overall survival in the phase 3 IMpower130 trial (NCT02367781). Median overall survival for advanced NSCLC patients who received atezolizumab in combination with chemotherapy was 18.6 months, compared with 13.9 months for patients who received chemotherapy alone (hazard ratio, 0.80; 95% confidence interval, 0.64-0.99; P = .0384) in the intention-to-treat wild-type population of 681 patients.
Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone, according to the company press release.
chemotherapy for first-line treatment of adults with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
Atezolizumab has been previously approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations. The monoclonal antibody is also approved to treat adults with metastatic NSCLC who have disease progression during or following chemotherapy, and for those with extensive-stage SCLC.
The current approval was based on a demonstrated improvement in overall survival in the phase 3 IMpower130 trial (NCT02367781). Median overall survival for advanced NSCLC patients who received atezolizumab in combination with chemotherapy was 18.6 months, compared with 13.9 months for patients who received chemotherapy alone (hazard ratio, 0.80; 95% confidence interval, 0.64-0.99; P = .0384) in the intention-to-treat wild-type population of 681 patients.
Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone, according to the company press release.
chemotherapy for first-line treatment of adults with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
Atezolizumab has been previously approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations. The monoclonal antibody is also approved to treat adults with metastatic NSCLC who have disease progression during or following chemotherapy, and for those with extensive-stage SCLC.
The current approval was based on a demonstrated improvement in overall survival in the phase 3 IMpower130 trial (NCT02367781). Median overall survival for advanced NSCLC patients who received atezolizumab in combination with chemotherapy was 18.6 months, compared with 13.9 months for patients who received chemotherapy alone (hazard ratio, 0.80; 95% confidence interval, 0.64-0.99; P = .0384) in the intention-to-treat wild-type population of 681 patients.
Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone, according to the company press release.
FDA issues warning for CDK 4/6 inhibitors
The Food and Drug Administration is warning that the entire class of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors used to treat advanced breast cancer may cause rare but severe inflammation of the lungs.
“We reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, called interstitial lung disease and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities,” the FDA said in a press statement.
The overall benefit of CDK 4/6 inhibitors, however, is still greater than the risks when used as prescribed, the agency said.
CDK 4/6 inhibitors are used in combination with hormone therapies to treat adults with hormone receptor–positive, human epidermal growth factor 2–negative advanced or metastatic breast cancer that has spread to other parts of the body. The FDA approved the CDK 4/6 inhibitors palbociclib (Ibrance) in 2015 and ribociclib (Kisqali) and abemaciclib (Verzenio) in 2017, based on improvements in progression-free survival.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe interstitial lung disease and/or pneumonitis, the FDA said.
The Food and Drug Administration is warning that the entire class of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors used to treat advanced breast cancer may cause rare but severe inflammation of the lungs.
“We reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, called interstitial lung disease and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities,” the FDA said in a press statement.
The overall benefit of CDK 4/6 inhibitors, however, is still greater than the risks when used as prescribed, the agency said.
CDK 4/6 inhibitors are used in combination with hormone therapies to treat adults with hormone receptor–positive, human epidermal growth factor 2–negative advanced or metastatic breast cancer that has spread to other parts of the body. The FDA approved the CDK 4/6 inhibitors palbociclib (Ibrance) in 2015 and ribociclib (Kisqali) and abemaciclib (Verzenio) in 2017, based on improvements in progression-free survival.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe interstitial lung disease and/or pneumonitis, the FDA said.
The Food and Drug Administration is warning that the entire class of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors used to treat advanced breast cancer may cause rare but severe inflammation of the lungs.
“We reviewed CDK 4/6 inhibitors cases from completed and ongoing clinical trials undertaken by manufacturers and their postmarket safety databases that described specific types of inflammation of the lungs, called interstitial lung disease and pneumonitis. Across the entire drug class, there were reports of serious cases, including fatalities,” the FDA said in a press statement.
The overall benefit of CDK 4/6 inhibitors, however, is still greater than the risks when used as prescribed, the agency said.
CDK 4/6 inhibitors are used in combination with hormone therapies to treat adults with hormone receptor–positive, human epidermal growth factor 2–negative advanced or metastatic breast cancer that has spread to other parts of the body. The FDA approved the CDK 4/6 inhibitors palbociclib (Ibrance) in 2015 and ribociclib (Kisqali) and abemaciclib (Verzenio) in 2017, based on improvements in progression-free survival.
Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease and/or pneumonitis. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams in patients in whom infectious, neoplastic, and other causes have been excluded. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe interstitial lung disease and/or pneumonitis, the FDA said.
FDA approves darolutamide for nonmetastatic CRPC
The Food and Drug Administration has approved darolutamide for nonmetastatic, castration-resistant prostate cancer.
The approval was based on improved metastasis-free survival (MFS) in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-resistant prostate cancer.
Median MFS was 40.4 months (95% confidence interval, 34.3 months to not reached) for patients treated with darolutamide, compared with 18.4 months (95% CI, 15.5-22.3 months) for those receiving placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P less than .0001), according to the FDA.
MFS is defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
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In ARAMIS, patients were randomized 2:1 to receive either 600 mg darolutamide orally twice daily (n = 955) or matching placebo (n = 554). All patients received a gonadotropin-releasing hormone analog concurrently or had a previous bilateral orchiectomy. Twelve patients with previous seizure histories were treated on the darolutamide arm.
Overall survival data is not yet mature, the FDA said.
The most common adverse reactions in patients who received darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common on the darolutamide arm, while seizure incidence was similar in the two arms (0.2%).
The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, the FDA said.
Darolutamide is marketed as Nubeqa by Bayer HealthCare Pharmaceuticals.
The Food and Drug Administration has approved darolutamide for nonmetastatic, castration-resistant prostate cancer.
The approval was based on improved metastasis-free survival (MFS) in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-resistant prostate cancer.
Median MFS was 40.4 months (95% confidence interval, 34.3 months to not reached) for patients treated with darolutamide, compared with 18.4 months (95% CI, 15.5-22.3 months) for those receiving placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P less than .0001), according to the FDA.
MFS is defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
[embed:render:related:node:194824]
In ARAMIS, patients were randomized 2:1 to receive either 600 mg darolutamide orally twice daily (n = 955) or matching placebo (n = 554). All patients received a gonadotropin-releasing hormone analog concurrently or had a previous bilateral orchiectomy. Twelve patients with previous seizure histories were treated on the darolutamide arm.
Overall survival data is not yet mature, the FDA said.
The most common adverse reactions in patients who received darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common on the darolutamide arm, while seizure incidence was similar in the two arms (0.2%).
The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, the FDA said.
Darolutamide is marketed as Nubeqa by Bayer HealthCare Pharmaceuticals.
The Food and Drug Administration has approved darolutamide for nonmetastatic, castration-resistant prostate cancer.
The approval was based on improved metastasis-free survival (MFS) in the randomized ARAMIS trial of 1,509 patients with nonmetastatic, castration-resistant prostate cancer.
Median MFS was 40.4 months (95% confidence interval, 34.3 months to not reached) for patients treated with darolutamide, compared with 18.4 months (95% CI, 15.5-22.3 months) for those receiving placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P less than .0001), according to the FDA.
MFS is defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
[embed:render:related:node:194824]
In ARAMIS, patients were randomized 2:1 to receive either 600 mg darolutamide orally twice daily (n = 955) or matching placebo (n = 554). All patients received a gonadotropin-releasing hormone analog concurrently or had a previous bilateral orchiectomy. Twelve patients with previous seizure histories were treated on the darolutamide arm.
Overall survival data is not yet mature, the FDA said.
The most common adverse reactions in patients who received darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common on the darolutamide arm, while seizure incidence was similar in the two arms (0.2%).
The recommended darolutamide dose is 600 mg (two 300-mg tablets) administered orally twice daily with food. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy, the FDA said.
Darolutamide is marketed as Nubeqa by Bayer HealthCare Pharmaceuticals.
FDA approves bevacizumab-bvzr for several cancers
The Food and Drug Administration has approved bevacizumab-bvzr (Zirabev) – a biosimilar to bevacizumab (Avastin) – for the treatment of five cancers: metastatic colorectal cancer (mCRC); unresectable, locally advanced, recurrent or metastatic non-squamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.
Approval was based on “review of a comprehensive data package which demonstrated biosimilarity of [bevacizumab-bvzr] to the reference product,” Pfizer said in a statement announcing the approval.
Bevacizumab-bvzr is the second bevacizumab biosimilar to be approved, following approval of Amgen’s bevacizumab-awwb (Mvasi) in 2017.
Warnings and precautions with the biosimilars, as with bevacizumab, include serious and sometimes fatal gastrointestinal perforation, surgery and wound healing complications, and sometimes serious and fatal hemorrhage.
The most common adverse events observed in bevacizumab patients are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.
Specific indications for the biosimilar are as follows:
Metastatic colorectal cancer
Bevacizumab-bvzr, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with mCRC.
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Bevacizumab-bvzr, in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin–based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product–containing regimen.
Bevacizumab-bvzr is not indicated for adjuvant treatment of colon cancer.
First-line nonsquamous non–small cell lung cancer
Bevacizumab-bvzr, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic NSCLC.
Recurrent glioblastoma
Bevacizumab-bvzr is indicated for the treatment of recurrent glioblastoma in adults.
Metastatic renal cell carcinoma
Bevacizumab-bvzr, in combination with interferon alfa, is indicated for the treatment of metastatic RCC.
Persistent, recurrent, or metastatic cervical cancer
Bevacizumab-bvzr, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Complete prescribing information can be found on the FDA website.
The Food and Drug Administration has approved bevacizumab-bvzr (Zirabev) – a biosimilar to bevacizumab (Avastin) – for the treatment of five cancers: metastatic colorectal cancer (mCRC); unresectable, locally advanced, recurrent or metastatic non-squamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.
Approval was based on “review of a comprehensive data package which demonstrated biosimilarity of [bevacizumab-bvzr] to the reference product,” Pfizer said in a statement announcing the approval.
Bevacizumab-bvzr is the second bevacizumab biosimilar to be approved, following approval of Amgen’s bevacizumab-awwb (Mvasi) in 2017.
Warnings and precautions with the biosimilars, as with bevacizumab, include serious and sometimes fatal gastrointestinal perforation, surgery and wound healing complications, and sometimes serious and fatal hemorrhage.
The most common adverse events observed in bevacizumab patients are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.
Specific indications for the biosimilar are as follows:
Metastatic colorectal cancer
Bevacizumab-bvzr, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with mCRC.
[embed:render:related:node:147160]
Bevacizumab-bvzr, in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin–based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product–containing regimen.
Bevacizumab-bvzr is not indicated for adjuvant treatment of colon cancer.
First-line nonsquamous non–small cell lung cancer
Bevacizumab-bvzr, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic NSCLC.
Recurrent glioblastoma
Bevacizumab-bvzr is indicated for the treatment of recurrent glioblastoma in adults.
Metastatic renal cell carcinoma
Bevacizumab-bvzr, in combination with interferon alfa, is indicated for the treatment of metastatic RCC.
Persistent, recurrent, or metastatic cervical cancer
Bevacizumab-bvzr, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Complete prescribing information can be found on the FDA website.
The Food and Drug Administration has approved bevacizumab-bvzr (Zirabev) – a biosimilar to bevacizumab (Avastin) – for the treatment of five cancers: metastatic colorectal cancer (mCRC); unresectable, locally advanced, recurrent or metastatic non-squamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.
Approval was based on “review of a comprehensive data package which demonstrated biosimilarity of [bevacizumab-bvzr] to the reference product,” Pfizer said in a statement announcing the approval.
Bevacizumab-bvzr is the second bevacizumab biosimilar to be approved, following approval of Amgen’s bevacizumab-awwb (Mvasi) in 2017.
Warnings and precautions with the biosimilars, as with bevacizumab, include serious and sometimes fatal gastrointestinal perforation, surgery and wound healing complications, and sometimes serious and fatal hemorrhage.
The most common adverse events observed in bevacizumab patients are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.
Specific indications for the biosimilar are as follows:
Metastatic colorectal cancer
Bevacizumab-bvzr, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with mCRC.
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Bevacizumab-bvzr, in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin–based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product–containing regimen.
Bevacizumab-bvzr is not indicated for adjuvant treatment of colon cancer.
First-line nonsquamous non–small cell lung cancer
Bevacizumab-bvzr, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic NSCLC.
Recurrent glioblastoma
Bevacizumab-bvzr is indicated for the treatment of recurrent glioblastoma in adults.
Metastatic renal cell carcinoma
Bevacizumab-bvzr, in combination with interferon alfa, is indicated for the treatment of metastatic RCC.
Persistent, recurrent, or metastatic cervical cancer
Bevacizumab-bvzr, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Complete prescribing information can be found on the FDA website.
FDA approves pembrolizumab for advanced SCLC
The Food and Drug Administration has granted accelerated approval to pembrolizumab for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Approval was based on an overall response rate of 19% among 83 patients with SCLC who had disease progression on or after two or more prior lines of therapy enrolled in two nonrandomized trials, according to the FDA.
SCLC cohorts in KEYNOTE-028 and KEYNOTE-158 received either pembrolizumab 200 mg intravenously every 3 weeks (n = 64) or 10 mg/kg intravenously every 2 weeks (n = 19). Treatment continued until documented disease progression, unacceptable toxicity, or for a maximum of 24 months.
The ORR was 19% (95% confidence interval, 11%-29%), while the complete response rate was 2%. Responses were durable for 6 months or longer in 94% of the 16 responding patients.
Common adverse reactions included fatigue, decreased appetite, cough, nausea, and constipation. The most frequent serious adverse reactions were pneumonia and pleural effusion.
The recommended dosage for SCLC treatment is 200 mg, administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression, the FDA said.
Pembrolizumab is marketed as Keytruda by Merck.
The Food and Drug Administration has granted accelerated approval to pembrolizumab for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Approval was based on an overall response rate of 19% among 83 patients with SCLC who had disease progression on or after two or more prior lines of therapy enrolled in two nonrandomized trials, according to the FDA.
SCLC cohorts in KEYNOTE-028 and KEYNOTE-158 received either pembrolizumab 200 mg intravenously every 3 weeks (n = 64) or 10 mg/kg intravenously every 2 weeks (n = 19). Treatment continued until documented disease progression, unacceptable toxicity, or for a maximum of 24 months.
The ORR was 19% (95% confidence interval, 11%-29%), while the complete response rate was 2%. Responses were durable for 6 months or longer in 94% of the 16 responding patients.
Common adverse reactions included fatigue, decreased appetite, cough, nausea, and constipation. The most frequent serious adverse reactions were pneumonia and pleural effusion.
The recommended dosage for SCLC treatment is 200 mg, administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression, the FDA said.
Pembrolizumab is marketed as Keytruda by Merck.
The Food and Drug Administration has granted accelerated approval to pembrolizumab for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Approval was based on an overall response rate of 19% among 83 patients with SCLC who had disease progression on or after two or more prior lines of therapy enrolled in two nonrandomized trials, according to the FDA.
SCLC cohorts in KEYNOTE-028 and KEYNOTE-158 received either pembrolizumab 200 mg intravenously every 3 weeks (n = 64) or 10 mg/kg intravenously every 2 weeks (n = 19). Treatment continued until documented disease progression, unacceptable toxicity, or for a maximum of 24 months.
The ORR was 19% (95% confidence interval, 11%-29%), while the complete response rate was 2%. Responses were durable for 6 months or longer in 94% of the 16 responding patients.
Common adverse reactions included fatigue, decreased appetite, cough, nausea, and constipation. The most frequent serious adverse reactions were pneumonia and pleural effusion.
The recommended dosage for SCLC treatment is 200 mg, administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression, the FDA said.
Pembrolizumab is marketed as Keytruda by Merck.
FDA approves trastuzumab-anns for HER2-positive breast, gastric cancer
The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.
This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.
Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.
In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.
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Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.
Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.
The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.
The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.
This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.
Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.
In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.
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Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.
Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.
The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.
The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.
This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.
Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.
In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.
[embed:render:related:node:169841]
Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.
Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.
The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.