- The FDA designates Bayer's (OTCPK:BAYRY) supplemental New Drug Application seeking approval for Stivarga (regorafenib) for the second-line treatment of unresectable hepatocellular carcinoma for Priority Review, shortening the review clock to six months.
- Stivarga is currently approved for the treatment of colorectal cancer and gastrointestinal stromal tumors.
- Regorafenib inhibits a family of enzymes called kinases which play key roles in tumor growth and progression.
- Previously: Bayer files regulatory applications seeking approval of regorafenib for the second-line treatment of liver cancer (Nov. 7, 2016)
FDA grants accelerated review for Bayer's Stivarga marketing application for liver cancer
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