European approval for Nexavar carcinoma treatment
The European Commission has approved oral tablets used to help treat patients with a common form of liver cancer.
The European Commission has approved oral tablets used to help treat patients with a common form of liver cancer.
The Nexavar sorafenib drugs have been approved by the commission for treatment in patients with hepatocellular carcinoma (HCC). This is the first approved systemic therapy for HCC and the only one shown to significantly improve overall survival in patients with the disease, according to Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals.
Regulatory filings for HCC are under review in countries around the world including the US and, most recently, Japan. Nexavar is approved in more than 60 countries for the treatment of patients with advanced kidney cancer.
"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," said Arthur Higgins, chairman of the executive committee of Bayer HealthCare. "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. Most importantly, it allows us to offer patients and medical professionals the potential to improve treatment outcomes for this devastating disease."
"Liver cancer is one of the cancers in which the number of related deaths continues to increase," said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals. "This second approval for Nexavar - first in advanced kidney cancer and now, less than two years later in HCC, demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today's unmet needs in cancer. We will move swiftly to make Nexavar rapidly available to patients."
The EC's decision to approve Nexavar is based on positive data from the international Phase 3 placebo-controlled Sorafenib HCC Assessment Randomised Protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival by 44% in patients with HCC (HR=0.69; p=0.0006) versus placebo.