Bayer HealthCare and Onyx Pharmaceuticals have announced FDA priority review designation for Nexavar (sorafenib) supplemental new drug application for the treatment of radioactive iodine-refractory differentiated thyroid cancer.
Nexavar is an oral multi-kinase inhibitor approved in the US for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma.
Bayer HealthCare Pharmaceuticals US medical affairs vice president and head Pamela Cyrus said, "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."
Onyx Pharmaceuticals global R&D and technical operations executive vice president Pablo Cagnoni said, "Sorafenib could offer an FDA-approved treatment option for patients with this type of thyroid cancer."
Results from the study of sorafenib in locally advanced or metastatIc patients with radioactive iodine refractory thyroid cancer trial, an international, multicenter, placebo-controlled study, were included in the submission which formed the basis for the approval.
