Despite previous approval by the FDA for nivolumab as a treatment for patients with small-cell lung cancer (SCLC) whose disease progressed after platinum-based chemotherapy and at least one prior line of therapy, the manufacturer announced it was withdrawing the indication due to the findings of confirmatory studies.  

The manufacturer’s release noted that nivolumab had been the first new treatment approved for SCLC patients in nearly two decades.  

However, in those two years, the release noted that "the treatment landscape has continued to evolve, leading to the availability of more options for patients with SCLC, across multiple lines of therapy."

Data from the CheckMate-451 and CheckMate-331 trials showed that the treatment did not meet its primary endpoint of overall survival benefit. 

"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," Abderrahum Oukessou, MD, vice president, thoracic cancers development lead, 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 needs 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."

The release stated that SCLC patients currently being treated with nivolumab should consult with their providers on the future of their care.  


By Adam Hochron