The Medical Letter on Drugs and Therapeutics
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1415
Regorafenib (Stivarga) for Metastatic Colorectal Cancer and GIST (online only)
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Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated with multiple other regimens specified in the labeling. It has also been approved for use in treatment-refractory, locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST).

CLINICAL STUDIES — Metastatic Colorectal Cancer – Approval of regorafenib for metastatic colorectal cancer was based on a placebo-controlled, double-blind trial in 760 patients with previously treated metastatic colorectal cancer. Patients were randomized 2:1 to treatment with 160 mg of regorafenib or placebo for the first 21 days of each 28-day cycle. Both median overall survival (6.4 months vs. 5.0 months) and median progression-free survival (1.9 months vs. 1.7 months) were significantly longer with regorafenib than with placebo. ... more      

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Title: Regorafenib (Stivarga) for Metastatic Colorectal Cancer and GIST (online only)
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