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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