By Saabira Chaudhuri 
 

Bayer AG (BAYRY) and Onyx Pharmaceuticals (ONXX) said the U.S. Food and Drug Administration has granted Priority Review designation to the supplemental New Drug Application for sorafenib as a treatment for locally advanced or metastatic radioactive iodine-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 FDA needs to complete its review by Dec. 25.

The oral multi-kinase inhibitor sorafenib, also called Nexavar, is approved in the U.S. for the treatment of patients with unrespectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma.

According to the two companies, Nexavar is thought to inhibit both the tumor cell and tumor vasculature.

"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," head of U.S. Medical Affairs for Bayer HealthCare Pamela A. Cyrus said.

The news comes after Onyx on Sunday agreed to be acquired by Amgen Inc. (AMGN) for roughly $10.4 billion, the latest proposed takeover aimed at tapping into growth expected from the cancer-drug industry.

Shares of Onyx closed Monday at $123.49, while American depositary shares of Bayer closed at $118.25. Both companies' stocks were inactive premarket.

Write to Saabira Chaudhuri at saabira.chaudhuri@wsj.com

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