Bayer's Stivarga Tablets Approved In Europe
LEVERKUSEN (dpa-AFX) - Bayer HealthCare, an unit of German conglomerate Bayer AG (BYR.L, BAYRY.PK, BAYZF.PK), and Onyx Pharmaceuticals, Inc. (ONXX) announced the European Commission's approval of Stivarga tablets for the treatment of adult patients with metastatic colorectal cancer or mCRC. This approval was based on data from the pivotal Phase III CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) study.
In September 2012, Stivarga was approved by the FDA to treat patients with mCRC who have been treated earlier with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
The complete results from the CORRECT trial were presented at the 48th Annual Meeting of the American Society of Clinical Oncology in June 2012 and published online on November 22, 2012, in The Lancet.
In the U.S., Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.
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