CHMP recommends Stivarga for treatment of GIST- Bayer
The oncology compound regorafenib (Stivarga) from BayerHealthCare has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with unresectable or metastatic Gastrointestinal Stromal Tumours (GIST) which progressed on or are intolerant to prior treatment with imatinib and sunitinib. The decision of the European Commission on the approval is expected in the third quarter of 2014.
The CHMP decision is based on the results of the pivotal Phase III GRID trial which showed that regorafenib plus best supportive care (BSC) significantly improved progression-free survival (PFS) compared to placebo plus BSC (HR=0.268 [95% CI 0.185-0.388], p<0.0001) in patients with metastatic and or unresectable gist who were previously treated with imatinib and sunitinib. the median pfs was 4.8 months in the regorafenib arm versus 0.9 months in the placebo arm p>< 0.0001).
Stivarga is already approved in the EU for the treatment of patients with metastatic Colorectal Cancer (mCRC).
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