Zoom imageDr. Daniel Korr analyzes the division of cancer cells using a laser scanning microscope.
Bayer HealthCare’s investigational compound regorafenib has been granted fast-track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.
The granting of “fast track” status is designed to facilitate the development, and expedite the review, of drugs to treat serious diseases where there is an unmet medical need. Regorafenib is a novel, oral multi-kinase inhibitor in the final phase of clinical development for GIST.
“People with this condition need new therapeutic options as quickly as possible,” said Dr. Kemal Malik, Head of Global Development at Bayer HealthCare and a member of the company’s Executive Committee. “The decision to fast-track regorafenib therefore represents a milestone for this group of patients.”