WASHINGTON, Feb 25 The U.S. Food and Drug
Administration said on Monday it has approved Bayer AG's
drug Stivarga for the treatment of a rare type of
gastrointestinal tract cancer.
Stivarga is already approved to treat colon cancer that has
progressed after prior treatment or that has spread to other
parts of the body. Bayer will now also be able to market the
drug as a treatment for gastrointestinal stromal tumors (GIST).
Stivarga, known chemically as regorafenib, was tested in 199
patients with GIST that could not be surgically removed and had
progressed after treatment with Novartis AG's Gleevec
and Pfizer Inc's Sutent.
Patients taking Stivarga had a delay in tumor growth
progression of 4.8 months, compared with 0.9 months for patients
in the placebo group.
Shannon Campbell, vice president and general manager of
Bayer's oncology business, said in a telephone interview that
the drug will be priced on a par with the $9,350 per 28-day
cycle of treatment set for the drug's use in colon cancer.
Under an agreement signed in 2011, Onyx Pharmaceuticals
Inc will receive a 20 percent royalty payment on global
sales of Stivarga. The agreement followed a dispute over how
closely related the treatment is to Nexavar, a kidney and liver
cancer drug that the companies co-developed.
Bayer and Onyx will jointly market Stivarga in the United
States. Bayer will market it alone in the rest of the world.
Stivarga is a pill that works by blocking several enzymes
that promote cancer growth.