Bristol Myers Squibb withdraws Opdivo for small cell lung cancer indication
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Bristol Myers Squibb withdrew nivolumab from the U.S. market for the treatment of patients with small cell lung cancer that progressed after platinum-based chemotherapy and at least one other therapy, according to a press release.
Nivolumab (Opdivo, Bristol Myers Squibb) received FDA accelerated approval for this indication in 2018 based on an analysis of surrogate endpoints from the phase 1/phase 2 CheckMate 032 trial showing an improvement in response rates and duration of response among patients with small cell lung cancer.
However, the confirmatory CheckMate 451 and CheckMate 331 trials failed to meet their primary endpoints of OS.
“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,” Abderrahim Oukessou, MD, vice president and thoracic cancers development lead at Bristol Myers Squibb, said in the release. “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.”
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