FDA OKs Nexavar for unresectable HCC

Bayer Healthcare, a division of Germany's Bayer, and US biopharmaceutical firm Onyx Pharmaceuticals, say that the Food and Drug Administration has extended its approval of the co-developed anticancer agent Nexavar (sorafenib). The new ruling clears the drug for the treatment of patients suffering unresectable hepatocellular carcinoma.

The FDA's decision is based on data from the Phase III SHARP trial, which demonstrated that Nexavar brought about a 44% improvement in patient survival in comparison with placebo (10.7 months versus 7.9 months). Earlier this month, the European Medicines Agency (EMEA) issued a similar approval decision for the HCC indication, also based on the SHARP findings.