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The U.S. Food and Drug Administration has accepted the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for priority review for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.


The FDA will be evaluating data from the international, multicenter, placebo-controlled DECISION trial, which included 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer (including papillary, follicular, Hurthle cell, and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer. The patients in the trial were randomized to receive 400 milligrams of oral sorafenib twice daily or a matching placebo. Ninety-six percent of randomized patients had metastatic disease.


The primary endpoint of the study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors. Secondary endpoints included overall survival, time to progression, response rate, and duration of response.


The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act. The date for the completion of review by the FDA of the supplemental New Drug Application of Nexavar is December 25.

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Nexavar, currently 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, is marketed by Bayer HealthCare and Onyx Pharmaceuticals.