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news.Bayer HealthCare has received the US Food and Drug Administration's (FDA) fast track designation for its experimental drug, regorafenib (BAY 73-4506).
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Regorafenib is indicated as a treatment for patients who are suffering from metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite at least imatinib and sunitinib as prior treatments.
The company has initiated a randomized, double-blind, placebo-controlled Phase III study of regorafenib plus best supportive care versus placebo plus best supportive care, in January.
The trial is intended to recruit 170 patients, who will be randomized in a 2:1 ratio to receive either regorafenib or placebo.
Bayer HealthCare Executive Committee member and Global Development head Kemal Malik said this milestone is an important step in the overall development of regorafenib.