Bristol Myers Squibb (BMS) statement on Opdivo small cell lung cancer U.S. indication.

In 2018, Opdivo (nivolumab) from BMS was granted accelerated approval by the FDA for the treatment of patients with small cell lung cancer (SCLC) whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy. The accelerated approval was based on Opdivo’s effect on surrogate endpoints from the Phase 1/II CheckMate -032 trial of patients with advanced or metastatic solid tumors. The trial demonstrated encouraging response rates and duration of response with Opdivo in SCLC, an aggressive and difficult-to-treat cancer. However, subsequent confirmatory studies in different treatment settings, CheckMate -451 and CheckMate -331, did not meet their primary endpoints of overall survival.In consultation with the FDA, BMS made the decision to withdraw this indication from the U.S. market. The company took this action in accordance with the Agency’s standard procedures for evaluating accelerated approvals that have not met their post-marketing requirements and as part of a broader industry-wide evaluation. Patients who are being treated with Opdivo for SCLC should consult with their healthcare provider in all aspects of their care.