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FDA Approves Nexavar for Use in Advanced Kidney Cancer

FDA Approves Nexavar for Use in Advanced Kidney Cancer

WEST HAVEN, Connecticut—The Food and Drug Administration (FDA) has approved Nexavar (sorafenib tosylate) tablets for the treatment of patients with advanced renal cell carcinoma. Nexavar, a multikinase inhibitor that has been shown to double progression-free survival in these patients, is the first FDA-approved treatment for this type of cancer in more than a decade, Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. (Emeryville, California), said in a news release.

"Nexavar is an oral anticancer drug that blocks tumor growth in new ways," said Arthur Higgins, chairman of Bayer Healthcare's executive committee. In preclinical models, Nexavar was shown to target members of classes of kinases known to be involved in both tumor cell proliferation and tumor angiogenesis. These kinases include RAF kinase, VEGFR-2, VEGFR-3, PDGFR-?, KIT, and FLT-3.

12 Years of Work

Hollings C. Renton, chairman, president and CEO of Onyx, said that "the approval of Nexavar reflects the culmination of 12 years of hard work by countless dedicated scientists and clinicians, as well as the selfless participation of individuals suffering from advanced kidney cancer. We thank all of these groups for their important contributions to Nexavar's development."

The companies also announced that a new program, the Resources for Expert Assistance and Care Helpline (REACH), is available to answer questions about Nexavar treatment, reimbursement, and patient support (call 1-866- 639-2827).

"As a kidney cancer survivor, I'm pleased that there is a new treatment available for patients with this deadly disease—a disease for which additional treatment options are welcome," commented Bill Bro, president of the Kidney Cancer Association. "Breakthroughs in research over the last several years have given renewed hope to patients with advanced kidney canacer who previously had few treatment options."

Phase III Trial

Nexavar's FDA approval was based on phase III data from the largest randomized placebo-controlled trial ever conducted in patients with advanced renal cell cancer, the companies said. The international phase III study was reported at the 2005 American Society of Clinical Oncology (ASCO) meeting by Bernard Escudier, MD, of the Gustave-Roussy Institute, Paris (see ONI July 2005, page 1). The study involved 905 randomized patients with histologically or cytologically confirmed unresectable and/or metastatic renal cell cancer of clear cell histology.


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