Fast Track Designation for Regorafenib for GIST

Bayer Healthcare Pharmaceuticals announced that the FDA has granted Fast Track designation for regorafenib (BAY 73-4506) for the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients whose disease has progressed despite at least imatinib and sunitinib as prior treatments. Patients are currently being enrolled in a Phase 3 study of regorafenib + best supportive care vs. placebo + best supportive care with a primary endpoint of progression-free survival and other secondary endpoints.

Regorafenib is an oral multikinase inhibitor being developed for treating GIST and other cancers.

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