NEW DRUGS Stivarga for Advanced Colon Cancer
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چکیده
NEW DRUGS Stivarga for Advanced Colon Cancer Regorafenib (Stivarga, Bayer) has been approved for patients with treatmentrefractory metastatic colorectal cancer. The drug is a multikinase inhibitor. The FDA’s approval was based primarily on the 760-patient CORRECT trial. Progression-free survival was only slightly improved (a median of 2 months with the study drug versus 1.7 months with placebo). A boxed warning mentions the risk of severe and fatal liver toxicity. Regorafenib was approved 1 month ahead of schedule and was reviewed under the FDA’s fast-track system. This medication has also shown promise for treating gastrointestinal stromal tumors. Regorafenib is discussed in this month’s Pharmaceutical Approval Update column on page 622. Source: FDA, September 27, 2012; Fierce Biotech, MedPage Today, September 27, 2012
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