Bayer Healthcare was granted orphan drug designation by the FDA for its drug candidate, regorafenib, for the treatment of gastrointestinal stromal tumors (GIST). In January, Bayer began enrolling patients in a randomized, double-blind, placebo-controlled Phase 3 study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable GIST whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

Regorafenib (also known as BAY 73-4506) is an oral multi-kinase inhibitor being developed for treating GIST and other cancers.

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