The Food and Drug Administration cleared Stivarga for patients whose gastrointestinal stromal tumors have progressed after trying standard therapies, the agency said today in a statement. Leverkusen, Germany-based Bayer jointly promotes the therapy, with South San Francisco, California-based Onyx receiving royalties of 20 percent on global sales.
Stivarga, known as regorafenib, was first approved by the FDA in September for advanced colorectal cancer patients whose disease progressed after standard therapies. It carries a boxed warning on severe and fatal liver toxicity. Stivarga has the potential for peak annual sales of 1 billion euros ($1.3 billion) with multiple approved uses, Bayer said in December.
The latest cancer the drug is meant for, called GIST, can start anywhere in the gastrointestinal tract and mostly affects people older than 50, according to the American Cancer Society. As many as 5,000 people are diagnosed with GIST every year, the organization said.
Patients taking Stivarga lived 4.8 months without their disease worsening, compared with 0.9 months for patients on placebo, according to a presentation of late-stage clinical trial results at a medical meeting in June.
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