BRIEF—Bristol-Myers seeks first-line lung cancer label for Opdivo/Yervoy

The US regulator will review a submission from Bristol Myers Squibb to broaden the label for Opdivo (nivolumab) and Yervoy (ipilimumab), plus chemo, for certain people with non-small cell lung cancer (NSCLC).

The label update would include first-line treatment for people with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations.

Under Priority Review and with Fast Track designation, the US FDA will provide a decision by August 6, 2020.

The company has also applied for a label update in this indication in Europe, and in Japan, together with co-developer Ono Pharmaceutical.