In 2018, nivolumab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of patients with SCLC whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy. The accelerated approval was based on nivolumab’s effect on surrogate endpoints from the phase I/II CheckMate 032 trial for patients with advanced or metastatic solid tumors. The trial demonstrated encouraging response rates and duration of response with nivolumab 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, 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 postmarketing requirements and as part of a broader industry-wide evaluation. Patients who are being treated with nivolumab for SCLC should consult with their health-care provider in all aspects of their care.
“We believe in the power of science to address some of the most challenging diseases of our time, and so we pursue innovations with the goal of transforming patients’ lives,” said Abderrahim
Abderrahim Oukessou, MD
Oukessou, MD, Vice President, Thoracic Cancers Development Lead, Bristol Myers Squibb. “Although we are disappointed by the withdrawal, we appreciate that the FDA shared our commitment to bringing an innovative new therapy to patients with high unmet need when the science pointed in that direction. Similarly, we respect the FDA’s efforts to evaluate accelerated approvals across the industry to ensure the integrity of this important program.”
Two years ago, nivolumab was the first new therapy approved in this setting after nearly 20 years. Since that time, the treatment landscape has continued to evolve, leading to the availability of more options for patients with SCLC, across multiple lines of therapy.
Nivolumab and nivolumab-based combinations are important treatment options in multiple forms of cancer, with established long-term survival benefits in complex diseases, including thoracic cancers like non–small cell lung cancer and malignant pleural mesothelioma. As an organization, we remain focused on investigating the potential of nivolumab for people with cancer who may benefit and pursuing the next breakthroughs for patients in need.