EC clears Bayer/Onyx' Nexavar in HCC

The European Commission has granted marketing authorization to Nexavar (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma, the most common form of liver cancer. The novel multi-kinase inhibitor, co-developed by Germany's Bayer HealthCare Pharmaceuticals and Onyx, is the first approved systemic therapy for HCC and the only one shown to significantly improve overall survival in patients with the disease.

Additional regulatory filings for HCC are under review in countries around the world including the USA and, most recently, Japan. Nexavar is currently approved in more than 60 countries for the treatment of patients with advanced kidney cancer. On the day of the news, October 30, shares in USA-based Onyx rose 6.8% to $47.58 in midday trading, while Bayer stock fell 1.2% to 57.09 euros against a 0.5% slump in the German blue-chip DAX index.

The EC's decision is based on positive data from the international Phase III placebo-controlled SHARP trial, which demonstrated that Nexavar extended overall survival 44% in patients with HCC (p=0.0006) versus placebo. In the study, median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. No indication of imbalances was observed in serious adverse events between the Nexavar and placebo-treated groups with the most commonly observed adverse events in treated patients being diarrhea and hand-foot skin reaction, the firms noted.