FDA grants Priority Review designation to sNDA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental New Drug Application (sNDA) for the oral multi-kinase inhibitor Nexavar^® (sorafenib) tablets 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 review by the FDA of the sNDA is December 25, 2013.

"We are very pleased that the FDA has chosen to grant Priority Review to sorafenib," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This is an important milestone for sorafenib and the designation highlights the urgent need for new treatments for patients with this type of thyroid cancer who have limited or no treatment options."

"Sorafenib could offer an FDA-approved treatment option for patients with this type of thyroid cancer," said Pablo J. Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations, Onyx Pharmaceuticals.

DECISION Trial Design

The submission is based on 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 (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 were randomized to receive 400 mg of oral sorafenib twice daily (207 patients) or matching placebo (210 patients). 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 (RECIST). Secondary endpoints included overall survival, time to progression, response rate and duration of response. Safety and tolerability were also evaluated.