7/1/2013 2:51 AM ET
Bayer AG's (BAYZF.PK,BAYRY.PK,BYR.L) Bayer HealthCare and Onyx Pharmaceuticals (ONXX: Quote) Monday announced the submission of a supplemental New Drug Application or sNDA to the U.S. Food and Drug Administration for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.
An application has also been made for marketing authorization to the European Medicines Agency or EMA.
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, 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 in June.
Pablo Cagnoni, Executive Vice President, Global Research & Development and Technical Operations, Onyx Pharmaceuticals, said, "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."