Monday 30 June 2014

EMA recommends a variation to the terms of marketing authorisation for regorafenib

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product regorafenib (Stivarga). Stivarga is indicated for the treatment of adult patients with: 1. metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine based chemotherapy, an anti VEGF therapy and an anti EGFR therapy; 2. unresectable or metastatic GISTs who progressed on or are intolerant to prior treatment with imatinib and sunitinib. Read more here.

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