Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced that the State Food and Drug Administration (SFDA) of China has approved Nexavar (sorafenib) tablets for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancer drug, is the first systemic therapy for HCC patients in China and the only treatment to significantly improved overall survival in patients with the disease.
The approval was based on two international double-blind, placebo-controlled Phase-3 trials that evaluated more than 800 patients, who received no prior systemic therapy.
"China has the highest number of liver cancer patients worldwide with more than 340,000 new cases diagnosed each year and it is continuing to rise," said Gunnar Riemann, PhD, member of the executive committee of Bayer HealthCare. "We are proud to be at the forefront of liver cancer treatment with Nexavar and are hopeful that patients in China can potentially have their lives extended by treatment with Nexavar," Gunnar said.
"This is another significant milestone in a region where patients are in dire need of a therapy that improves survival," said N Anthony Coles, MD, president and chief executive officer, Onyx Pharmaceuticals, Inc. "The approval in liver cancer in China comes less than two years after the approval in advanced kidney cancer and proves that Nexavar is and will continue to be an important foundational therapy in multiple patient populations," expressed Anthony.
Nexavar is currently approved in more than 40 countries for the treatment of liver cancer and in more than 70 countries for the treatment of advanced kidney cancer. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced Renal Cell Carcinoma (RCC), who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of other cancers, including non-small cell lung cancer (NSCLC), metastatic melanoma, breast cancer and, as an adjuvant therapy, for kidney cancer and liver cancer.
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 per cent of the primary malignant liver tumours in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.