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.

Arthur Higgins, chairman of Bayer HealthCare's executive committee, commented that "the approval of Nexavar in HCC marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a priority basis [the drug was cleared for renal cell carcinoma early last year; Marketletter January 9, 2006]." He added that the decision would likely establish the drug as the standard systemic therapy for the treatment of liver cancer.