Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. announced that the European Commission has granted marketing authorization to Nexavar (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer.
Nexavar, an oral anti-cancer drug, is the first and only approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease. Additional regulatory filings in HCC are under review in countries around the world including the US and, most recently, in Japan. Nexavar is currently 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. This milestone will likely establish Nexavar as the standard of care in 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," said Arthur J. Higgins, chairman of the executive committee, Bayer HealthCare.
"Liver cancer is one of the few cancers in which the number of related deaths continues to increase. 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," said Hollings C. Renton, chairman, president and chief executive officer, Onyx Pharmaceuticals, Inc.
The European Commission'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 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. The primary objective of the study was to compare overall survival in patients administered Nexavar versus those administered placebo. Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhoea and hand-foot skin reaction. Based on these data, a supplemental New Drug Application for Nexavar was granted Priority Review status by the US Food and Drug Administration (FDA) in August. Most recently, the regulatory filing in Japan has been submitted.
HCC, the most common form of liver cancer, is responsible for about 90 percent 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. Over 600,000 cases of liver cancer are diagnosed worldwide each year (about 54,000 in Europe, 19,000 in the U.S. and 390,000 in China, Korea and Japan) and incidence is increasing. Currently, the 5-year survival rate for patients with liver cancer in Europe is less than 8 percent. The 5-year survival rate for liver cancer patients in the United States is 11 percent and less than 10 percent in Asia among patients with non-resectable tumours.
Nexavar targets both the tumour cell and tumour vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC. Therefore, blocking signalling through Raf-1 may offer therapeutic benefits in HCC.
Nexavar is currently approved in more than 50 countries, including the United States and the European Union, for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved 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 adjuvant therapy for kidney cancers, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC).
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar, a small molecule drug, with Bayer HealthCare. For more information about Onyx's pipeline and activities.
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.