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The Food and Drug Administration has granted accelerated approval to nivolumab (Opdivo) for treating patients with metastatic small-cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Approval was based on an overall response rate and duration of response in the monotherapy arm of the multicohort phase 1/2 CheckMate 032 trial. Of 109 patients with SCLC and progression after at least one previous platinum-containing regimen, 12% responded to monotherapy treatment with nivolumab regardless of PD-L1 status, 12 patients had a partial response, and one patient had a complete response.
Among responders, the median duration of response was 17.9 months. Results of the trial were presented at the ASCO annual meeting and published online in The Lancet Oncology in 2016.
Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration.
The approved dose is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity, the company said in a press statement announcing the approval.
The checkpoint inhibitor was approved for treating patients with metastatic non–small-cell lung cancer with progression on or after platinum-based chemotherapy in 2015.
The Food and Drug Administration has granted accelerated approval to nivolumab (Opdivo) for treating patients with metastatic small-cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Approval was based on an overall response rate and duration of response in the monotherapy arm of the multicohort phase 1/2 CheckMate 032 trial. Of 109 patients with SCLC and progression after at least one previous platinum-containing regimen, 12% responded to monotherapy treatment with nivolumab regardless of PD-L1 status, 12 patients had a partial response, and one patient had a complete response.
Among responders, the median duration of response was 17.9 months. Results of the trial were presented at the ASCO annual meeting and published online in The Lancet Oncology in 2016.
Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration.
The approved dose is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity, the company said in a press statement announcing the approval.
The checkpoint inhibitor was approved for treating patients with metastatic non–small-cell lung cancer with progression on or after platinum-based chemotherapy in 2015.
The Food and Drug Administration has granted accelerated approval to nivolumab (Opdivo) for treating patients with metastatic small-cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.
Approval was based on an overall response rate and duration of response in the monotherapy arm of the multicohort phase 1/2 CheckMate 032 trial. Of 109 patients with SCLC and progression after at least one previous platinum-containing regimen, 12% responded to monotherapy treatment with nivolumab regardless of PD-L1 status, 12 patients had a partial response, and one patient had a complete response.
Among responders, the median duration of response was 17.9 months. Results of the trial were presented at the ASCO annual meeting and published online in The Lancet Oncology in 2016.
Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration.
The approved dose is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity, the company said in a press statement announcing the approval.
The checkpoint inhibitor was approved for treating patients with metastatic non–small-cell lung cancer with progression on or after platinum-based chemotherapy in 2015.