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FDA Approves Onyx and Bayer Colorectal Cancer Drug

From Associated Press (September 27, 2012)

NEW YORK -- The Food and Drug Administration on Thursday approved a new colorectal cancer pill developed by Onyx Pharmaceuticals Inc. and Bayer HealthCare.

The drug is called Stivarga, and it is designed to block several enzymes that promote cancer growth. The FDA approved Stivarga as a treatment for colorectal cancer that has progressed after treatment and metastasized, or spread to other parts of the body. The agency approved the drug about one month ahead of schedule.

In clinical studies, patients treated with Stivarga and standard treatment had median survival of 6.4 months, compared to 5 months for patients who were received only standard treatment.

The companies will market the drug together. Bayer developed Stivarga, and under an agreement between the companies, Onyx will get royalties on sales of the drug.

Stivarga, which was developed under the name regorafenib, is the second colorectal cancer drug to win FDA approval recently. In August the agency backed Sanofi’s drug Zaltrap as a treatment for metastatic colon cancer in combination with chemotherapy.

The FDA says colorectal cancer is the third-most common cancer in the U.S. and the third leading cause of cancer death. It said around 143,460 cases are expected to be diagnosed in 2012, and about 51,690 people will die of the disease.

Onyx and Bayer have also asked the FDA to approve Stivarga as a treatment for gastrointestinal stromal tumors, which mostly occur in the stomach or small intestine.

The drug is approved with a warning connected to sever and sometimes fatal liver toxicity that was observed in some patients in studies.

The most common side effects of Stivarga in clinical trials included weakness or fatigue, loss of appetite, diarrhea, mouth sores, weight loss, infection, high blood pressure, changes in voice volume or quality, and hand-foot syndrome, a condition in which small amounts of the drug leak out of the blood vessels in the palms and the soles of the feet, causing reddened skin, tenderness, and peeling.

Shares of Onyx rose 2.6 percent to $84.64 on Thursday. The stock rose 36 cents to $85 in aftermarket trading.

Bayer HealthCare is a subsidiary of Germany’s Bayer AG.

Posted: September 2012