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# Opdivo Approved for Resectable Lung Cancer
- URL: https://www.fdaweb.com/opdivo-approved-for-resectable-lung-cancer/
- Published: 2024-10-03T12:00:00.000Z
- Updated: 2026-09-14T14:43:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157915

FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery, for adults with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. 

Approval was based on data from the CHECKMATE-77T (NCT04025879) trial involving 461 patients with previously untreated and resectable NSCLC (Stage IIA to select stage IIIB), according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-nivolumab-resectable-non-small-cell-lung-cancer?ref=fdaweb.com). “At the prespecified interim analysis, overall survival (OS) was not formally tested for statistical significance; however, a descriptive analysis revealed no detriment,” it says, adding that adverse reactions were similar to those documented in other clinical trials of nivolumab with chemotherapy.