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WAYNE, N.J., and SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has granted priority review for an investigational cancer treatment created by Bayer and Onyx Pharmaceuticals.
The companies said Bayer's new drug application for oral multikinase inhibitor regorafenib initially was filed in April for the treatment of patients with metastatic colorectal cancer, whose disease has progressed after approved standard therapies. The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists.
Under the Prescription Drug User Fee Act, the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.