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
jennifer.corbett@dowjones.com
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