Orphan drug designation granted to regorafenib for gastrointestinal stromal tumors (GIST)

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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