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Monday, November 11, 2019

FDA accepts Bristol-Myers application for Opdivo + Yervoy for liver cancer

Under Priority Review status, the FDA accepts Bristol-Myers Squibb’s (NYSE:BMY) supplemental marketing application seeking approval to use Opdivo (nivolumab) + Yervoy (ipilimumab) to treat patients with advanced hepatocellular carcinoma (HCC) who have previously received Bayer’s Nexavar (sorafenib), a Breakthrough Therapy indication.
The agency’s action date is March 10, 2020.

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