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FDA approves Stivarga for treatment of colorectal cancer

The FDA announced that it approved Stivarga to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body. Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. Stivarga is being approved one month ahead of the product’s prescription drug user fee goal date of Oct. 27, the date the agency was scheduled to complete review of the drug application. Stivarga is being approved with a Boxed Warning alerting patients and health care professionals that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies. Stivarga is marketed by Onyx Pharmaceuticals (ONXX) and Bayer (BAYRY).