FDA Approves Presurgical, Postsurgical Opdivo for NSCLC
The Food and Drug Administration has approved Opdivo before and after surgery for some with non-small cell lung cancer.
The FDA has approved Opdivo as a presurgical and postsurgical treatment for some patients with non-small cell lung cancer.
The Food and Drug Administration (FDA) has approved neoadjuvant (presurgical) Opdivo (nivolumab) with platinum-doublet chemotherapy followed by postsurgical single-agent Opdivo for adults with resectable (removable by surgery) tumors at least 4 centimeters and/or node-positive disease non-small cell lung cancer (NSCLC) and no known EGFR mutations or ALK rearrangements, the agency has announced.
The effectiveness of the treatment was observed in the CHECKMATE-77T clinical trial of 461 patients with previously untreated and resectable stage 2A to stage 3B NSCLC. Patients in the trial received either Opdivo or placebo with platinum-based chemotherapy every three weeks for up to four cycles, followed after surgery by either single-agent Opdivo or placebo every four weeks for up to 13 cycles.
Median event-free survival (the time a patient lives without disease worsening or complications) was not reached (meaning it occurred in less than half of patients) in the Opdivo arm and 18.4 months in the chemotherapy arm. At the time of the interim analysis, overall survival (the time a patient lives regardless of disease status) was not tested for statistical significance, but the FDA reported that a descriptive analysis showed no detriment.
Side effects were similar to other clinical trials of Opdivo and chemotherapy, with 5.3% of patients treated with Opdivo unable to undergo surgery due to side effects compared to 3.5% of the placebo arm. The agency reported that 4.5% of those who received presurgical Opdivo and surgery had surgical delays due to side effects, compared to 3.9% of the placebo arm.
According to the FDA, the recommended dosage of Opdivo is 360 milligrams every three weeks before surgery and 480 milligrams every four weeks after surgery, and it should be administered prior to chemotherapy when given on the same day.
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