Nexavar (Sorafenib) Granted Priority Review for Thyroid Cancer
Approval decision expected in December (August 27)
The FDA has granted a Priority Review designation to the supplemental New Drug Application (sNDA) for the oral multikinase inhibitor Nexavar (sorafenib, Bayer/Onyx Pharmaceuticals) tablets, which are under evaluation for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.
The FDA grants priority review status to drug candidates that may offer a significant improvement in treatment over existing options.
The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA’s review is December 25, 2013.
Submission of the sNDA was based on results from the DECISION (StuDy of SorafEnib in LoCally Advanced or MetastatIc PatientS With Radioactive Iodine-Refractory ThyrOid CaNcer) trial, an international, multicenter, placebo-controlled study. A total of 417 patients with locally advanced or metastatic, RAI-refractory, differentiated thyroid cancer who had not been treated with chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or the VEGF receptor, or other targeted agents for thyroid cancer were randomly assigned to receive 400 mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients).
The study’s primary endpoint was progression-free survival. Secondary endpoints included overall survival, time to progression, response rate, and duration of response.
Nexavar (sorafenib) is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma and for patients with advanced renal cell carcinoma. The drug is thought to inhibit both the tumor cell and tumor vasculature.
Source: Onyx Pharmaceuticals; August 27, 2013.