The European Commission’s decision to approve Nexavar is based on positive data from the international Phase III placebo-controlled sorafenib hepatocellular carcinoma (HCC) assessment randomized protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival by 44% in patients with HCC versus placebo.
Arthur Higgins, chairman of the executive committee of Bayer HealthCare, said: “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. This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of HCC and shows the dedication of health authorities to make Nexavar available as quickly as possible.”