WAYNE, N.J. and EMERYVILLE, Calif., July 28 /PRNewswire-FirstCall/ - BayerHealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) todayannounced that the State Food and Drug Administration (SFDA) of China hasapproved Nexavar(R) (sorafenib) tablets for the treatment of patients withunresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer.Nexavar is the first and only oral targeted therapy to significantly improveoverall survival in patients with the disease.
The approval was based on two international Phase 3 double-blind,placebo-controlled trials that evaluated more than 800 patients who receivedno prior systemic therapy.
"China has the highest number of liver cancer patients worldwide with morethan 340,000 new cases diagnosed each year and the incidence is continuing torise," said Gunnar Riemann, PhD, member of the Executive Committee of BayerHealthCare. "We are proud to be at the forefront of liver cancer treatmentwith Nexavar and are hopeful that patients in China can potentially have theirlives extended by treatment with Nexavar."
"This is another significant milestone in a region where patients are indire need of a therapy that improves survival," said N. Anthony Coles, MD,president and chief executive officer, Onyx Pharmaceuticals, Inc. "Theapproval in liver cancer in China comes less than two years after the approvalin advanced kidney cancer and proves that Nexavar is and will continue to bean important foundational therapy in multiple patient populations."
Hepatocellular carcinoma is the most common form of liver cancer and isresponsible for about 90 percent of the primary malignant liver tumors inadults. Liver cancer is the sixth most common cancer in the world and thethird leading cause of cancer-related deaths globally. More than 600,000cases of liver cancer are diagnosed worldwide each year (more than 400,000 inChina, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000in the United States) and the incidence is increasing. In 2002, approximately600,000 people died of liver cancer including approximately 370,000 in China,South Korea and Japan, 57,000 in the European Union, and 13,000 in the UnitedStates.(1)(2)
In the Asia-Pacific region, more than eight percent of the generalpopulation is infected with chronic hepatitis B and between two and fourpercent is infected with chronic hepatitis C.(3)(4) Both infections are theleading causes of primary liver cancer worldwide.
Nexavar's Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinicalstudies, Nexavar has been shown to target members of two classes of kinasesknown to be involved in both cell proliferation (growth) and angiogenesis(blood supply) -- two important processes that enable cancer growth. Thesekinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has arole in HCC; therefore blocking signaling through Raf-1 may offer therapeuticbenefits in HCC.
Nexavar is currently approved in more than 40 countries for liver cancerand in more than 70 countries for the treatment of patients with advancedkidney cancer. Nexavar is also being evaluated by the companies,international study groups, government agencies and individual investigatorsas a single agent or combination treatment in a wide range of cancers,including metastatic melanoma, lung cancer, breast cancer and as an adjuvanttherapy for kidney cancer.
Important Safety Considerations For Patients Taking Nexavar
Based on the currently approved U.S. package insert for the treatment ofpatients with unresectable hepatocellular carcinoma, hypertension may occurearly in the course of therapy and blood pressure should be monitored weeklyduring the first six weeks of therapy and treated as nee