B-MS first to get FDA review for two I-O drugs in lung cancer

22 June 2018

The first ever application for a combination of two immuno-oncology (I-O) drugs in lung cancer has been accepted by the US Food and Drug Administration (FDA).

Bristol-Myers Squibb (NYSE: BMY) is set to hear by February 20 whether it has been successful with a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase.

Sabine Maier, development lead for thoracic cancers at the US pharma major, said: “Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients.

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