Bayer, Onyx submit sNDA to FDA, marketing authorization application to EMA for Nexavar tablets

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Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and an application for marketing authorization to the European Medicines Agency (EMA) for the oral multi-kinase inhibitor Nexavar® (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.

"The filings in the U.S. and Europe for sorafenib for the potential treatment of this type of thyroid cancer bring us closer to addressing an unmet medical need for these patients who have limited or no treatment options," said Kemal Malik, M.D., Member of the Bayer HealthCare Executive Committee and Head of Global Development. "We are committed to exploring sorafenib's potential applicability in hard-to-treat cancers."

"Based on results from clinical studies we believe sorafenib could potentially provide a new option for the treatment of differentiated thyroid cancer that no longer responds to radioactive iodine therapy," said Pablo J. Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations, Onyx Pharmaceuticals.

The regulatory submission is based on data from the Phase 3 DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, an international, multicenter, placebo-controlled study. In the trial, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo. Results from the study were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2013.

DECISION Trial Design
The DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial was 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.

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