Nivolumab's SCLC Approval Is Pulled From US Market


Results of confirmatory trials showed that the drug did not meet its primary endpoints for patients with small cell lung cancer.

Bristol Myers Squibb announced that it is withdrawing nivolumab (Opdivo) from the US market for the treatment of patients with small cell lung cancer (SCLC) whose disease progressed after chemotherapy and 1 or more prior lines of therapy.

The indication was granted accelerated approval in 2018 after promising response rates and duration of response was seen with nivolumab in patients with SCLC in the phase 1/2 CheckMate-032 trial. However, confirmatory trials (CheckMate-451 and CheckMate-331) showed that the drug did not meet the primary endpoints of overall survival.

“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 Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb, in a 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,” Oukessou said.

Oncology nurses and physicians should discuss new treatment options or best next steps for patients with SCLC who are currently undergoing treatment with nivolumab.

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