FDA Approves Stivarga for Colorectal Cancer
- Fri, 9/28/12 - 10:23am
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The FDA approved Stivarga (regorafenib) to treat patients with metastatic colorectal cancer. The drug, a multi-kinase inhibitor marketed by Bayer HealthCare Pharmaceuticals, was approved under the FDA's priority review program.
The approval was based on results of a randomized trial of 760 patients who had previously been treated for metastatic colorectal cancer. They received treatment until the disease progressed or side effects became unacceptable.
Patients who took regorafenib plus best supportive care had a median survival of 6.4 months compared with 5.0 months for the placebo plus best supportive care group. Median progression-free survival was 2.0 months in the regorafenib group and 1.7 months in the placebo group.
The drug's labeling contains a boxed warning that some patients treated with regorafenib had severe and fatal liver toxicity.
The FDA's news release is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321271.htm