FDA accepts Nexavar HCC sNDA for review

Bayer Healthcare Pharmaceuticals, a US unit of Germany's Bayer, and US biopharmaceutical firm Onyx Pharmaceuticals say that a supplemental New Drug Application seeking approval for Nexavar (sorafenib) as a treatment for hepatocellular carcinoma, has been accepted for priority review by the Food and Drug Administration.

The firms, which have been collaborating on cancer drug development since 1994 (Marketletters passim), said that, because Nexavar targets a range of mediators involved in both cell proliferation and angiogenesis, including the Raf-1 kinase that has been shown to play a role in HCC, it potentially offers considerable therapeutic benefits as a treatment for the disease.

The sNDA submission, completed earlier this year (Marketletter July 2), is comprised of data from the Phase III SHARP trial, in which Nexavar was shown to extend patient survival by 44%, compared with placebo. These findings also formed the basis of the supplemental Marketing Authorization Application that Bayer HealthCare filed with the European Medicines Agency (EMEA) in June (Marketletter June 25).