Bayer drug ‘to be established as standard liver cancer therapy’

Bayer HealthCare has forecast that its drug Nexavar (sorafenib) will become the standard treatment for liver cancer.

Together with Onyx Pharmaceuticals, the company has this week announced that the compound has had its supplemental new drug application as a therapy for unresectable hepatocellular carcinoma (HCC) approved by the US Food and Drug Administration (FDA).

Nexavar was approved as a treatment for HCC – the most common form of liver cancer- in Europe last month.

The decision from the FDA was based on positive clinical trial data from the phase III Sharp study which showed the compound to improve overall survival in patients with HCC by 44 per cent when compared to placebo, with median overall survival of 10.7 months.

Arthur J Higgins, chairman of the executive committee of Bayer HealthCare, said: “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 review basis, making it rapidly available to patients who previously had limited treatment options.”

He added that this approval marks a turning point in the development of treatment options for patients affected by liver cancer.

Nexavar was first approved for marketing by the European Commission as a treatment for advanced renal cell carcinoma in July 2006.