Nexavar gains FDA priority review for thyroid cancer sNDA

German drug major Bayer (BAYN: DE) and partner Onyx Pharmaceuticals (Nasdaq: ONXX), which has just agreed a $10.4 billion takeover by Amgen (The Pharma Letter August 27), have been granted Priority Review designation from the US Food and Drug Administration for their 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 Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the sNDA is December 25, 2013. The companies applied for approval of this new indication for Nexavar, which generated sales of over $1 billion last year, last month (TPL July 1). Nexavar is already approved in other indications like hepatocellular carcinoma and advanced renal cell carcinoma.

"We are very pleased that the FDA has chosen to grant Priority Review to sorafenib," said Pamela Cyrus, vice president and head of US Medical Affairs, Bayer HealthCare Pharmaceuticals, adding: "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."