FDA Approves Nexavar (sorafenib) for Advanced Renal Cell Carcinoma
Leverkusen – December 20, 2005 -- Bayer HealthCare AG announced today that the U.S. Food and Drug Administration (FDA) has approved Nexavar® (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer. Nexavar is co-developed by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. and has been shown to double progression free survival in patients with advanced RCC. It is the first FDA-approved treatment for this type of cancer in more than a decade. The companies expect that Nexavar will be shipped, primarily to specialty pharmacies, and available to patients within the next 24 hours.
“The FDA approval of Nexavar is a crucial step for patients with advanced kidney cancer therapy. We are delighted that, thanks to the rapid granting of approval, we will now be able to make this urgently needed product available earlier than planned,” said Werner Wenning, Chairman of the Board of Management of Bayer AG. “This also marks a great success for the realignment of our pharmaceuticals business and a major accomplishment in the commercial realization of the company's oncology franchise.”
The FDA approved Nexavar based on data from the largest ever randomized, placebo-controlled, international trial in patients with advanced renal cell carcinoma, in which 130 centers participated. Treatment with Nexavar resulted in approximately a doubling of progression-free-survival.
“This approval is just the start of Nexavar's life cycle. We are thankful to all of the RCC investigators and patients that have been involved, and are hopeful that Nexavar will become a promising therapeutic option for other malignant tumors as well,” said Arthur Higgins, chairman of Bayer HealthCare's executive committee.” In addition to Nexavar, we have other promising oncology compounds in various stages of development. Oncology is a priority development area for Bayer, and we will continue to invest aggressively and selectively in the most powerful and promising compounds.”
Bayer HealthCare has also filed for regulatory approval with the European Medicines Evaluation Agency (EMEA), where drugs can be granted marketing authorization for all EU countries through a centralized procedure. Pending a favourable review market availability is possible in the EU countries in late 2006. In addition, filings have been completed in Switzerland, Australia, Brazil, Canada and Mexico.
New Treatment Paradigms, Improved Outcomes
Innovations in cancer research and development are moving towards treating the disease chronically and through personalized medicine. With the approval of Nexavar, Bayer is at the leading edge of developments that may ultimately change the way we approach and manage diseases such as cancer.
Today's newer, targeted anti-cancer therapies are attacking tumors by arresting their growth: cutting off growth signals, stopping new blood supply, or both. Often times, these cytostatic therapies do not have the high level of toxicity associated with older, cytotoxic drugs, and, therefore, may be more tolerable and sustainable for patients to take over a longer period of time.
“Nexavar is one of a new breed of cancer therapies,” said Dr. Wolfgang Plischke, Head of Bayer HealthCare's Pharmaceuticals Division. “Bringing us closer to the day when oncologists will have a war chest of effective, highly tolerable, and very combinable cancer treatments that may more closely resemble the long-term, 'drug-cocktail' regimens associated with other serious diseases like diabetes or even HIV.”
“This is an exciting time in oncology-targeted therapies, in combination with current treatment and diagnostics, will help us find the right therapies for specific tumors and help us prolong life,” said Plischke. “At Bayer, we're committed to being a major part of that excitement and will continue to invest heavily in the promising compounds and diagnostic testing in our pipeline.”
Nexavar is the first, oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-ß, KIT, and FLT-3.
Nexavar has been studied in more than 20 tumor types and in more than 4,000 patients to date. It is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer. A Phase III clinical trial in non-small cell lung cancer (NSCLC) is planned for the first half of 2006.
About Bayer HealthCare AG
Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately EUR 8.5 billion in 2004, is one of the world's leading, innovative companies in the health care and medical products industry.
The company combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics, Diabetes Care and Pharmaceuticals divisions. 35,300 people were employed by Bayer HealthCare worldwide in 2004.
Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Source: Bayer HealthCare AG
Posted: December 2005
- FDA Approves Nexavar to Treat Metastatic Differentiated Thyroid Cancer - November 22, 2013
- Bayer and Onyx Pharmaceuticals Announce Submission of FDA and EMA Applications for Nexavar (sorafenib) for the Treatment of Radioactive Iodine-Refractory Differentiated Thyroid Cancer - July 1, 2013
- FDA Approves Nexavar (sorafenib) for Unresectable Hepatocellular Carcinoma - November 19, 2007
- Nexavar Granted FDA Priority Review for Treatment of Liver Cancer - August 20, 2007
- Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma - September 14, 2005
- Bayer and Onyx Complete Filing of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma - July 11, 2005
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