As expected, Bayer and partner Onyx Pharmaceuticals’ Nexavar has received the green light in Europe to be sold as a treatment for liver cancer.
The German firm noted that European Commission has granted marketing authorisation to Nexavar (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma, making it “the first and only approved systemic drug therapy for liver cancer” and the only one shown to significantly improve overall survival in patients with the disease.
The approval, which comes just over a month after European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on the drug, is based on positive data from the Phase III SHARP trial. That study demonstrated that the drug extended overall survival by 44% in patients with HCC versus placebo and the study revealed no significant differences in serious adverse event rates between Nexavar and placebo-treated groups.
Based on the SHARP data, a supplemental New Drug Application for Nexavar was granted priority review status by the US Food and Drug Administration in August and since then a regulatory filing in Japan has been submitted. Arthur Higgins, head of Bayer HealthCare, added that the approval of Nexavar, a novel multi-kinase inhibitor, “represents an unprecedented advance for patients with HCC who, until now, had no approved systemic treatment options,” noting that “this milestone will likely establish Nexavar as the standard of care in HCC”.
Nexavar, which is currently approved in more than 50 countries to treat advanced kidney cancer, brought in 60 million euros in the second quarter but getting approval for the liver cancer indication is going to push that figure much higher and Bayer is looking to get it onto the market as soon as possible.