The FDA approved the first time in 30 years the indication of antitumor Nexavar for treating liver cancer. Also, the drug received approval from European authorities.
The FDA approval was based on positive results achieved in international phase III study, placebo-SHARP (Sofafenib HCC Assessment Randomized Protocol, “Protocol assessment randomized to sorafenib in HCC”) which demonstrated that Nexavar extended in 44% overall survival of patients with liver cancer compared with placebo.
Nexavar two years ago became the first new drug against kidney cancer, the drug was developed jointly with Bayer HealthCare AG and Onyx Pharmaceuticals, Inc.
Hepatocellular carcinoma is the most common type of liver cancer and is responsible for about 90% of primary malignant liver tumors in adults. It is the sixth most common tumor worldwide and the third type of cancer causes more deaths. Are diagnosed each year more than 600 000 new cases worldwide and the incidence is increasing.