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WAYNE, N.J. — The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.
Bayer announced that the FDA had granted fast-track designation to BAY 73-4506 (regorafenib), designed to treat patients with gastrointestinal stromal tumors whose disease has spread to other parts of the body or whose tumors can’t be removed through surgery, and whose disease has progressed despite treatment with other drugs. The FDA grants fast-track designation to aid the development and expedite review of drugs that treat serious diseases and fill an unmet medical need.
“There is an unmet medical need for this specific patient population,” Bayer HealthCare Pharmaceuticals head of global development Kemal Malik said. “This milestone is an important step in the overall development of regorafenib.”