UPDATE 2-US panel backs Lilly drug for cancer prevention

(Adds panel member comments, background, share price)

By Lisa Richwine

ROCKVILLE, Md., July 24 (Reuters) - Eli Lilly and Co.'s (LLY.N) blockbuster osteoporosis drug Evista should be approved for reducing the risk of breast cancer in some women, a U.S. advisory panel said on Tuesday.

The Food and Drug Administration will make the final decision but usually follows panel recommendations. Lilly said the FDA was expected to rule in September.

The drugmaker sells Evista now for treating and preventing the bone-thinning of osteoporosis. The company is seeking additional clearance to promote Evista as a way to prevent breast cancer.

The FDA panel of outside experts voted 8-6 to urge Evista's approval for reducing the risk of invasive breast cancer in post-menopausal women with osteoporosis.

Members also voted 10-4 to recommend the drug for lowering the chances of getting breast cancer in post-menopausal women at high risk for the disease.

Panel member Dr. Antonio Grillo-Lopez, a retired oncologist, said Evista "shows at least similar efficacy and perhaps a better safety profile" than tamoxifen, the only medicine now approved for breast cancer prevention.

Lilly said Evista has effects similar to those of the hormone estrogen in the bone, which helps fight osteoporosis, but blocks estrogen in breast tissue. The company presented studies of 37,000 women that compared Evista to a placebo or tamoxifen.

Studies found Evista cut the risk of developing breast cancer that needs estrogen to grow when tested against a placebo, FDA reviewers said. Taking Evista did not appear to reduce the chances of breast cancers that do not need estrogen to advance, the FDA staff analysis said.

One study showed 862 women must be treated with Evista for a year to prevent an invasive breast cancer in one of them, FDA reviewers said. They said Evista's benefits should be weighed against serious risks, such as blood clots or possibly dying from a stroke.

"The number of patients needed to treat for some benefit is astounding," said Dr. Ronald Richardson, a panel member and medical oncology consultant at the Mayo Clinic.

Sales of Evista, known generically as raloxifene, topped $1 billion in 2006.

Competing osteoporosis drugs include Merck & Co Inc.'s (MRK.N) Fosamax, and Roche Holding AG's (ROG.VX) and GlaxoSmithKline Plc's (GSK.L) Boniva.

Shares of Lilly, which earlier Tuesday posted better-than-expected quarterly earnings and raised its 2007 forecast, were 1.4 percent higher in afternoon trading on the New York Stock Exchange to $57.97.

((Reporting by Lisa Richwine, editing by Tim Dobbyn; Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: LILLY EVISTA/

(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN24368196