Bayer seeks liver cancer OK for Nexavar

WAYNE, N.J., June 27 (UPI) -- Bayer and Onyx Wednesday filed a supplemental new drug application with the U.S. Food and Drug Administration for Nexavar for treating liver cancer.

Nexavar, which is currently approved for treating advanced kidney cancer, demonstrated improved overall survival in a phase 3 study involving patients with hepatocellular carcinoma, the most common form of liver cancer.

"After more than 100 clinical studies of many agents over three decades, Nexavar is the first drug therapy to demonstrate a significant survival benefit for patients with HCC, and, if approved, may fulfill a serious unmet need with a manageable toxicity profile," said Susan Kelley, Bayer's vice president of therapeutic area oncology.

In the phase 3 SHARP trial, which supports the sNDA filing, patients who received Nexavar experienced a 44-percent extension in overall survival, compared with those who got placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo groups.