FDA approves new treatment for advanced kidney cancer

Susan Jeffrey

December 22, 2005

Dec 22, 2005

Bethesda, MD - The Food and Drug Administration announced December 20, 2005 the approval of sorafenib tosylate (Nexavar, Bayer Pharmaceuticals/Onyx Pharmaceuticals) for the treatment of adults with advanced renal cell carcinoma, the most common type of kidney cancer [ 1 ].

"The approval of Nexavar to treat advanced kidney cancer brings a much-needed option for this group of cancer patients," said Dr Steven Galson (director, FDA Center for Drug Evaluation and Research [CDER]) in an FDA news release. "The FDA is working hard to support the development of new and effective treatments for patients with cancer and other serious illnesses who have limited alternatives."

Nexavar was developed by Onyx Pharmaceuticals Inc (Emeryville, CA) and Bayer Pharmaceuticals Corp (Westhaven, CT). The companies have also filed for approval of Nexavar in the European Union, Switzerland, Canada, Brazil, Australia, and Mexico.

Targets tumor cell proliferation and angiogenesis

The new therapy is an oral multikinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature, a release from the companies notes [ 2 ]. In preclinical models, it targeted kinases involved in tumor-cell proliferation and tumor angiogenesis, they write.

The drug's approval was based on phase 3 data from the "largest randomized, placebo-controlled trial ever conducted in patients with advanced renal cell cancer," the companies' release notes. Results showed treatment doubled progression-free survival vs placebo, from a median value of three months to six months with treatment, the release states.

"The median time to tumor progression or death in the Nexavar treated arm was 167 days compared with 84 days in people not treated with the drug," the FDA release added.

The benefit was seen in all subgroups, the companies' release notes, including those who had not received conventional treatment with biologics such as interleukin-2 or interferon-alpha. A planned interim survival analysis, based on 220 deaths, showed a nonsignificant survival benefit for Nexavar over placebo, with a hazard ratio of 0.72, the companies' release notes. "Additional analyses are planned at the time survival data mature."

The most common adverse events were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, nausea, pruritus, hypertension, vomiting, and anorexia, the companies' release said. "Grade 3 and 4 treatment-emergent adverse events were reported in 31% (vs 22% for placebo-treated patients) and 7% (vs 6% for placebo-treated patients) of Nexavar-treated patients, respectively."


  1. FDA. FDA approves new treatment for advanced kidney cancer. December 20, 2005. Available at: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01282.html.

  2. Onyx Pharmaceuticals. FDA approves Nexavar for treatment of patients with advanced kidney cancer [press release]. December 20, 2005. Available at: http://www.onyx-pharm.com/wt/page/pr_1135103068.



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