To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Nexavar® (Sorafenib) Approved for Hepatocellular Carcinoma in Europe URL: http://www.pslgroup.com/dg/21673E.htm Doctor's Guide October 30, 2007
Only Systemic Therapy Shown to Significantly Extend Overall Survival in Patients with Most Common Form of Liver Cancer WAYNE, NJ and EMERYVILLE, CA -- October 30, 2007 -- The European Commission has granted marketing authorization to Nexavar® (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 systemic therapy 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 the United States and, most recently, 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," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare. "This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of 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." "Liver cancer is one of the cancers in which the number of related deaths continues to increase," said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals, Inc. "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." 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% 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 these data, a supplemental New Drug Application for Nexavar was granted Priority Review status by the U.S. Food and Drug Administration (FDA) in August. These data, along with Phase 1 safety data, were submitted as part of a Marketing Authorization Application in Japan. HCC, the most common form of liver cancer, is responsible for about 90% of the primary malignant liver tumors in adults.1,2 Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.3 Over 600,000 cases of liver cancer are diagnosed worldwide each year3 (about 54,000* in Europe,4 19,000 in the United States,5 and 390,000 in China, Korea and Japan4) and incidence is increasing.6 In 2002 approximately 600,000 people died of liver cancer including 57,000* in Europe, 13,000 in the United States, and approximately 360,000 in China, Korea and Japan.4 Currently, the 5-year survival rate for patients with liver cancer in Europe is less than 8%.7 The 5-year survival rate for liver cancer patients is 11% in the United States,8 and less than 10% in Asia among patients with non-resectable tumors.9 Nexavar's Differentiated Mechanism Nexavar targets both the tumor cell and tumor 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 signaling through Raf-1 may offer therapeutic benefits in HCC. Important Safety Considerations for U.S. Patients Taking Nexavar A supplemental New Drug Application has been submitted to the U.S. Food and Drug Administration for Nexavar in the treatment of liver cancer, and is currently under review. Based on the currently approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered. Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals Inc. 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. International Agency for Cancer Research. GLOBOCAN 2002. Available at: http://www dep.iarc.fr. Accessed April 23, 2007. 4. Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5, Version 2.0. IARCPress, Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed October 15, 2007. 5. Jemal A et al. CA Cancer J Clin. 2007;57:43-66. 6. Ries LAG, Melbert D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L, Horner MJ, Howlader N, Eisner MP, Reichman M, Edwards BK (eds). SEER Cancer Statistics Review, 1975-2004, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2004/, based on November 2006 SEER data submission, posted to the SEER web site, 2007 7. Capocaccia, R. et al., "Hepatocellular Carcinoma: Trends of Incidence and Survival in Europe and the United States at the End of the 20th Century." American Journal of Gastroenterology 2007;102: 1661-1667. 8. American Cancer Society. Cancer Facts & Figures 2007. Atlanta: American Cancer Society: 2007. 9. Teo, T.K. and Fock, K.M. "Hepatocellular Carcinoma: An Asian Perspective." Digestive Diseases 2001:19: 263-268. SOURCE: Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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