FDA Grants Priority Review Designation To SNDA For Nexavar Tablets - Quick Facts

(RTTNews) - Bayer HealthCare (BAYZF.PK, BAYRY.PK, BYR.L) and Onyx Pharmaceuticals (ONXX) announced US FDA has granted Priority Review designation to the supplemental New Drug Application or sNDA for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer. The PDUFA date for completion of review by the FDA of the sNDA is December 25, 2013.

The FDA grants priority review status to drug candidates that may offer a significant improvement in treatment over existing options.

Nexavar is currently approved in more than 100 countries. Nexavar is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma.