Bayer, Onyx Receive Priority Review for Liver Treatment

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced that the FDA accepted their supplemental new drug application for Nexavar tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.

The submission, completed in June, was based on data from the Phase III SHARP trial, which demonstrated that Nexavar (sorafenib) extended overall survival by 44 percent in patients with HCC versus placebo, Bayer and Onyx said.

There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction, the companies said.

Based on this data, the companies also submitted a marketing authorization application to the European Medicines Agency in June.