To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Nexavar Becomes First Approved Systemic Treatment of Hepatocellular Carcinoma in Europe URL: http://www.pslgroup.com/dg/2171CA.htm Doctor's Guide November 13, 2007
LEVERKUSEN, GERMANY -- November 13, 2007 -- The European Commission has granted marketing authorization to Nexavar(R) (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar, an oral anti-cancer drug, is the first approved therapy in Europe for HCC and the only one shown to significantly improve overall survival in patients with the disease. Additional regulatory filings for HCC are under review in countries around the world including Canada. Currently, Nexavar has been issued marketing authorization with conditions in Canada, for the treatment of patients with locally advanced/metastatic kidney cancer. "Liver cancer is one of the cancers in which the number of related deaths continues to increase," said Dr. Shurjeel Choudhri, senior vice president, head of Medical and Scientific Affairs, Bayer HealthCare Pharmaceuticals. "This second approval for Nexavar in Europe – first in kidney cancer and now, less than two years later in liver cancer, demonstrates Bayer's commitment to expediting the clinical development of this innovative therapy to improve patient outcomes. Bayer is working with Health Canada to make Nexavar rapidly available to Canadian patients." The European Commission's decision to approve Nexavar is based on positive data from the international Phase 3 placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival by 44 per cent in patients with HCC (HR=0.69; P =.0006) versus placebo. In the study, median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. No indication of imbalances was observed in serious adverse events between the Nexavar and placebo-treated groups, with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on the SHARP Trial data, a submission was made to Health Canada requesting approval of a secondary indication for HCC. The safety and efficacy of Nexavar in HCC is under review by Health Canada, and marketing authorization has not been granted. "The approval in Europe 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 Dr. Jennifer Knox, SHARP trial clinical investigator, Medical Oncologist, Toronto. "It is encouraging to think that soon Canadian liver cancer patients could also have access to Nexavar, in addition to the kidney cancer patients who already benefit from this treatment. I am optimistic that Health Canada will approve Nexavar as a first-line treatment of HCC and that step will help provide patients with the potential to improve their treatment outcomes for this devastating disease." About Liver Cancer Hepatocellular carcinoma is the most common form of liver cancer and is responsible for approximately 90 per cent of the primary malignant liver tumors in adults.1, 2 It is the fifth most common cancer in the world3 and the third leading cause of cancer-related deaths globally.4 Mortality rates of liver cancer in Canada are on the rise, and for 2007, it is estimated that there will be approximately 1,350 newly diagnosed cases of liver cancer, an estimated half of which will be fatal.5, 6 Liver cancer is more prevalent in men than women, with 1,050 new diagnoses in men, compared to 300 in women.7 About Nexavar Nexavar targets both the tumor cell and tumor vasculature and is the only oral multi-kinase inhibitor that does not require patients to interrupt their treatment schedule. 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 (growth of new blood vessels) -- two important processes that enable cancer growth. Nexavar works by slowing tumor growth and by cutting off the blood supply to the tumor (angiogenesis). Nexavar acts on proteins called kinases which include RAF kinase, VEGFR-2, VEGFR-3, PDGFR-beta, KIT, FLT-3 and RET. Nexavar is currently approved in nearly 50 countries, including Canada, the United States and in the European Union, for the treatment of patients with advanced kidney cancer. In 2006, Therapeutic Products Directorate of Health Canada (TPD) granted a Notice of Compliance with Conditions (NOC/c) for Nexavar for treatment of patients with locally advanced / metastatic renal cell (clear cell) carcinoma who have failed prior cytokine therapy or considered unsuitable for such therapy. This authorization reflects the promising nature of the clinical evidence which will require additional confirmatory data. Products approved under Health Canada's NOC/c policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use. Nexavar is currently marketed in Canada for renal cell (clear cell) carcinoma, however, the product is not reimbursed by the government. In addition, it is being evaluated by Bayer, international study groups, government agencies or individual investigators as a single agent or combination treatment in a wide range of cancers, including as adjuvant therapy for kidney cancer, liver cancer, metastatic melanoma, non-small cell lung cancer and breast cancer. REFERENCES: 1 World Health Organization. Hepatitis B. Available at: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/. Accessed April 10, 2007 2 Penn State Milton S. Hershey Medical Center College of Medicine. Malignant Hepatoma. Available at: http://www.hmc.psu.edu/healthinfo/m/malignanthepatoma.htm. Accessed April 10, 2007. 3 World Health Organization. Estimates by WHO Region: Incidence. Available at: http://www.who.int/healthinfo/statistics/gbdwhoregionincidence2002.xls. Accessed April 10, 2007. 4 World Health Organization. Cancer Fact Sheet Number 297. Available at: http://www.who.int/mediacentre/factsheets/fs297/en/print.html. Accessed May 4, 2007. 5 Canadian Cancer Society. Canadian Cancer Encyclopedia. Available at: http://info.cancer.ca/E/CCE/cceexplorer.asp?tocid=25. Accessed May 16, 2007. 6 Canadian Cancer Society. Canadian Cancer Encyclopedia. Available at: http://info.cancer.ca/E/CCE/cceexplorer.asp?tocid=25. Accessed May 16, 2007. 7 Canadian Cancer Society. Canadian Cancer Encyclopedia. Available at: http://info.cancer.ca/E/CCE/cceexplorer.asp?tocid=25. Accessed May 16, 2007. 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