FDA Approves Bayer Colon Cancer Drug Stivarga to be Co-Marketed by Onyx Pharmaceuticals
Posted Sep 27 2012 6:28pm
Stivarga in clinical trials was shown to extend lives a little bit over 6 months. It is the second drug approved within the last couple of months for colorectal cancer. Patients in the trail also showed a delay in tumor growth. It does carry a black box warning that it can cause toxic liver problems and other common side effects include weakness or fatigue, loss of appetite, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia). The drug works by blocking enzymes that promote cancer growth. BD
WASHINGTON--The U.S. Food and Drug Administration on Thursday approved a new drug developed by Bayer AG ( BAYRY , BAYN .XE) to treat colon cancer that hasn't responded to treatment with currently available therapies.
The drug, which will be sold with the brand name Stivarga, will be co-marketed in the U.S. by Onyx Pharmaceuticals Inc. ( ONXX ). The company will receive a 20% royalty on global net sales of the product, also known by its generic name regorafenib.
Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. It is meant to treat patients with colorectal cancer that has progressed after treatment with other drugs and spread to other parts of the body.