FDA Approves Bayer AG Colon Cancer Drug Stivarga

   By Jennifer Corbett Dooren 
 

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.

The approval was primarily based on a 760 patient study. All of the patients had been previously treated with standard colon cancer drugs, which included chemotherapy, Avastin, Erbitux and Vectibix.

More than 500 patients were treated with regorafenib while about 250 received a placebo. Patients receiving regorafenib lived for an average of 6.4 months while those receiving a placebo lived for an average of five months.

 
   Write to Jennifer Corbett Dooren at [e-mail] 
 

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