Roche Holding AG (ROG.VX) Monday said the U.S. health regulator has approved its Avastin treatment for use kidney cancer, where it will go up against heated competition from established drugs from Pfizer Inc. (PFE), Wyeth and Bayer SE (BAY.XE).

The Basel-based drugmaker won approval after showing that patients suffering from kidney cancer lived nearly twice as long without the cancer growing when they took Avastin in combination with interferon alpha, another treatment.

Although there are far fewer kidney cancer patients than those suffering from breast, lung and colon cancer, the American Cancer Society says roughly 13,000 patients die annually of kidney cancer, the eighth most commonly diagnosed cancer in the U.S.

Roche's approval from the U.S. Food and Drug Administration was widely expected, and means the drug is set to compete in an intensely competitive market.

Established kidney cancer drugs include Nexavar, manufactored by Bayer and Onyx Pharmaceuticals Inc. (ONXX), Pfizer Inc's Sutent treatment and Wyeth's Torisel. Those drugs have carved out a large share of the market as sole treatments, without the use of interferon.

Nevertheless, analysts expect Avastin, which is already approved to treat advanced breast, lung, brain and colorectal cancer and had 2008 sales of $2.69 billion in the U.S., to make inroads into kidney cancer, in part because it is being studied for use in other combinations. Those include Novartis AG's (NVS) Afinitor, which works by attacking the mTOR protein, which is involved in tumor-cell division and blood-vessel growth.

Analysts lauded the approval but highlighted the small and crowded market.

"The approval was expected and we estimate that it could increase revenues by CHF300 million to CHF500 million," Bank Vontobel analyst Silvia Schanz said. She rates Roche at buy with a CHF185 target price.

Roche shares shrugged off the approval, partly because the drug's vetting was already priced into shares and doctors had already been using Avastin off-label, or before approval was formalized, in kidney cancer.

At 0755 GMT, the stock was CHF0.80 lower, or down 0.5%, at CHF167.70, bucking a 0.2% rise in the Stoxx 600 health index.

Avastin has been approved to treat kidney cancer in Europe since 2007.

 
   Company Web Site: http://www.roche.com

-By Katharina Bart, Dow Jones Newswires; +41 43 443 8043; katharina.bart@dowjones.com