CHMP recommends label expansion for Stivarga

|By:, SA News Editor

Europe's Committee for Medicinal Products for Human Use (CHMP) recommends that the European Medicines Agency (EMA) approve Bayer's (BAYRY) (BAYZF) Stivarga (regorafenib) as a treatment for adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. Stivarga is currently approved for the treatment of metastatic colorectal cancer (mCRC).

CHMP's decision is based on a Phase 3 clinical trial that showed a statistically significant improvement in progression-free survival (PFS) in patients receiving regorafenib plus best supportive care (BSC) compared to patients receiving placebo plus BSC. Median PFS in the test group was 4.8 months versus 0.9 months in the control arm.