The company has withdrawn the small cell lung cancer indication for Opdivo (nivolumab) based on discussions with the FDA, particularly focused on post-market studies that missed their primary endpoints of overall survival.
Bristol-Myers Squibb announced that it has withdrawn the indication for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer in the U.S. market.
Opdivo is a PD-1 (programmed death-1) immune checkpoint inhibitor that utilizes a patient’s immune system to produce an anti-tumor response. This decision was made based on consultation with the Food and Drug Administration (FDA), which took into consideration several subsequent studies — specifically CheckMate-451 and CheckMate-331 — which did not meet primary endpoints of overall survival, according to a statement from the company. The company took the action according to the FDA’s procedures for the assessment of accelerated approvals that did not meet requirements in post-market studies, in addition to an industry-wide evaluation.
“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 Dr. Abderrahim Oukessou, vice president of thoracic cancers development lead at Bristol-Myers Squibb, in the statement. “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.”
Opdivo was granted accelerated approval from the FDA in 2018 to treat patients with small cell lung cancer who experienced disease progression after platinum-based chemotherapy and one or more other lines of therapy. The original approval was based on findings from the CheckMate-032 trial, which resulted in promising response rates and duration of response in patients with small cell lung cancer, a rare subtype of lung cancer that accounts for 10% to 15% of all lung cancer diagnoses. At the time, this marked the first approval in the small cell lung cancer space in nearly two decades.
The statement from the company instructs patients who are currently being treated with Opdivo to consult with their health care provider regarding their care. Stay tuned to CURE® for further coverage on this action and to learn more about what patients need to know about this.
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