FDA Approves Third Indication for Bristol-Meyers' Opdivo

Friday, October 16, 2015


The FDA last week approved a third indication for Bristol-Myers Squibb’s Opdivo, this time to treat metastatic non-squamous non-small cell lung cancer that has progressed during or after platinum-based chemotherapy.

The approval means the PD-1 inhibitor can be used to treat both main types of NSCLC — squamous and non-squamous. Opdivo won the squamous indication in March.

The new indication comes a week after Merck’s Keytruda gained FDA approval to treat both kinds of NSCLC, becoming the first PD-1 inhibitor to do so. However, Keytruda is limited to patients whose tumors express the PD-L1 protein and Opdivo is not, potentially giving it a larger patient population.

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