BMS Gives Up on Small Cell Lung Cancer Indication for Opdivio

Bristol Myers Squibb (BMS) has withdrawn the U.S. indication for its blockbuster drug Opdivo (nivolumab) for the treatment of small cell lung cancer, following disappointing clinical trial results.

The FDA had granted accelerated approval for the indication in 2018, limiting it to patients with small cell lung cancer whose disease has progressed after platinum-based chemotherapy and at least one other line of therapy.

The approval was based on positive results from a phase1/2 trial in patients with advanced or metastatic solid tumors. But subsequent confirmatory studies in different treatment settings did not meet their primary endpoints of overall survival, BMS said.