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# Speedy Approval for Opdivo in Lung Cancer
- URL: https://www.fdaweb.com/speedy-approval-for-opdivo-in-lung-cancer/
- Published: 2022-03-07T12:00:00.000Z
- Updated: 2026-09-14T17:35:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151306

FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) 360 mg (injection for intravenous use) for adult patients with resectable non-small cell lung cancer (NSCLC). The approval came five days after the company said the submission was accepted for priority review and having a 7/13 user fee review action target date. The approval covers Opdivo’s use in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients in the neoadjuvant setting.

The approval is based on data from the CheckMate -816 trial, which the company describes as the first positive Phase 3 trial of an immunotherapy-based combination used before surgery for resectable NSCLC. The primary endpoints included event-free survival (EFS), pathologic complete response (pCR), and overall survival (OS).

In the trial, the Opdivo regimen showed a statistically significant improvement in EFS with a 37% reduction in the risk of progression, recurrence or death compared to chemotherapy alone, according to the company. Additionally, 24% of patients treated with Opdivo pCR compared to 2.2% of patients treated with chemotherapy alone. Bristol Myers noted that a prespecified interim analysis for OS did not cross the boundary for statistical significance.