Bristol Myers Squibb, in consultation with the Food and Drug Administration (FDA), has decided to withdraw the indication for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer (SCLC) whose disease has progressed after platinum-based chemotherapy and at least 1 other line of therapy.
In 2018, the FDA granted accelerated approval to Opdivo, a programmed death receptor-1 (PD-1) blocking antibody, for SCLC based on data from the phase 1/2 CheckMate -032 trial, which showed promising response rates and duration of response. However, subsequent confirmatory studies (CheckMate -451 and CheckMate -331) in different treatment settings showed that Opdivo failed to meet the primary end points of overall survival in patients with SCLC.
Under the FDA’s accelerated approval program, a drug may be approved earlier if it is intended to treat a serious condition or fills an unmet need; the approval is based on a surrogate end point that is thought to predict clinical benefit. A confirmatory trial is then required to prove clinical benefit. If the confirmatory trial does not show clinical benefit, the Agency can take steps to remove the drug or indication.
“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,” said Abderrahim Oukessou, MD, vice president, thoracic cancers development lead, Bristol Myers Squibb.
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Bristol Myers Squibb statement on Opdivo (nivolumab) small cell lung cancer U.S. indication. [press release]. Bristol Myers Squibb; December 29, 2020.