Opdivo Approved for Resectable Lung Cancer

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. “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.