29 December 2020 - In 2018, Opdivo (nivolumab) was granted accelerated approval by the U.S. FDA for the treatment of patients with small cell lung cancer 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 outcome from the Phase 1/2 CheckMate-032 trial of patients with advanced or metastatic solid tumours. The trial demonstrated encouraging response rates and duration of response with Opdivo in small cell lung cancer, 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 outcomes of overall survival.

In consultation with the FDA, we made the decision to withdraw this indication from the U.S. market. We 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 small cell lung cancer should consult with their health care provider in all aspects of their care.

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