February 13, 2008 / 12:41 AM / 12 years ago

Genentech's Avastin meets breast cancer study goal

NEW YORK (Reuters) - Genentech Inc said on Tuesday its cancer drug, Avastin, met the primary goal of prolonging progression-free survival when combined with chemotherapy in a breast cancer study, sending its shares up more than 3 percent.

The biotechnology company said results of the late-stage study support Avastin’s potential as a breast cancer treatment. It is already approved to treat colon and lung cancer and the company is awaiting a decision on breast cancer.

No new safety problems related to Avastin were observed in the study, which was sponsored by Roche Holding AG, the company said. The Swiss drugmaker holds a majority stake in Genentech and sells Genentech’s drugs outside the United States.

Avastin, considered Genentech’s most important drug by Wall Street analysts, had U.S. sales of $2.3 billion in 2007. Approval for breast cancer could significantly boost sales.

The company was expecting a U.S. Food and Drug Administration decision later this month on whether Avastin will be approved for breast cancer in combination with paclitaxel chemotherapy.

An FDA advisory panel in December narrowly voted to recommend rejecting Avastin for breast cancer, saying data from a previous study were insufficient to establish a favorable risk/benefit analysis for the drug’s use in this patient population.

“This may be what swings the balance for approval,” Cowen and Co analyst Ziad Bakri said of the new study results.

“News of a second progression-free survival study is obviously a positive, even with a different chemotherapy,” said Bakri, adding he expects the FDA to delay its approval decision while it reviews the new data.

Genentech’s said it has shared the new data, which tested the drug with docetaxel, with the FDA.

“We are pleased that a second Phase III study in this population of breast cancer patients showed a significant improvement in progression-free survival,” Hal Barron, Genentech’s chief medical officer said in a statement.

“The trial also demonstrated Avastin’s potential with a different chemotherapy in this disease,” he added.

Avastin was tested at two doses in combination with docetaxel in a study involving 736 patients, who had not received prior chemotherapy. At both doses, Avastin showed statistically significant improvement in the time patients lived without their disease advancing compared to patients who received chemotherapy and a placebo.

Genentech shares rose 3.7 percent to $72.48 in extended trading from their New York Stock Exchange close at $69.92.

Reporting by Bill Berkrot, editing by Leslie Gevirtz

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