Bayer, Onyx announce FDA approval of Nexavar tablets to treat kidney cancer

By E. Janene Geiss

Philadelphia, Dec. 20 - Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. announced Tuesday that the U.S. Food and Drug Administration has approved Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma, or kidney cancer.

Nexavar, which has been shown to double progression-free survival in patients with advanced kidney cancer, is the first FDA-approved treatment for this type of cancer in more than a decade, according to a company news release.

The companies said they expect that Nexavar will be shipped, primarily to specialty pharmacies, and available to patients within the next 24 hours.

"Nexavar is an oral anticancer drug that blocks tumor growth in new ways," Arthur Higgins, chairman of Bayer HealthCare's executive committee, said in the release.

"It has demonstrated the ability to prolong progression-free survival. Nexavar also has been shown to delay the progression of cancer in the majority of patients with a manageable side effect profile, an area that has been a challenge for patients and their physicians," Higgins added.

As part of the global registration strategy, a Marketing Authorization Application also was submitted to the European Medicines Agency in London in September 2005 for approval to market Nexavar within the European Union for the treatment of kidney cancer.

Filings also have been completed in Switzerland, Australia, Brazil, Canada and Mexico, officials said.

Nexavar's FDA approval was based on phase 3 data from the largest randomized, placebo-controlled trial ever conducted in patients with advanced renal cell cancer.

In the study, Nexavar doubled progression-free survival when compared to a placebo. Progression-free survival measures the time that a patient lives without evident tumor growth.

At the time of a planned interim survival analysis, based on 220 deaths, overall survival was longer for Nexavar than placebo with a hazard ratio (Nexavar over placebo) of 0.72. This analysis did not meet the prespecified criteria for statistical significance. Additional analyses are planned at the time survival data mature, officials said.

In the phase 3 trial, the most common reported treatment-emergent adverse events of any severity were diarrhea, rash/desquamation, fatigue, hand and foot skin reaction, alopecia, nausea, pruritus, hypertension, vomiting and anorexia. Grade 3 and 4 treatment-emergent adverse events were reported in 31% (versus 22% for placebo-treated patients) and 7% (versus 6% for placebo-treated patients) of Nexavar-treated patients, respectively, officials said.

Onyx, based in Emeryville, Calif., is a biopharmaceutical company engaged in the development of novel cancer therapies that target the molecular basis of cancer.

Bayer Pharmaceuticals Corp. is part of the operations of Bayer HealthCare AG, a subgroup of Leverkusen, Germany-based Bayer AG, a health care and medical products company.

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