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Tuesday, March 31, 2009

UPDATE 2-US panel sees brain cancer benefit with Roche drug

* FDA panel backs Roche's Avastin new use 10-0 vote

* Agency expected to rule on brain cancer use by May 5

* Company says data sufficient to win early approval

* Avastin treatment will cost $39,600 - spokeswoman (Adds details from panel, background on product, comments)

By Susan Heavey

WASHINGTON, March 31 (Reuters) - Early data for Roche Holding AG's (ROG.VX) drug Avastin shows enough promise in treating patients with a certain brain cancer to be considered for quick approval, a U.S. advisory panel said on Tuesday.

The drugmaker is seeking accelerated approval to market the drug for patients diagnosed with a recurrence of the particularly deadly disease after trying other therapies first. The drug, made by its recently acquired Genentech unit, is already used to treat lung, colon and breast cancers.

Data from two early studies showed enough of a response in patients whose disease did not advance and some whose tumors decreased in size to warrant faster approval before the company finishes a larger trial to confirm the benefit, the panel said in a 10-0 vote.

"I think these results are dramatic," said panel member Jay Loeffler, head of radiation oncology at Massachusetts General Hospital in Boston.

Many panelists also said they were optimistic that the company's larger, long-term trial would confirm Avastin's benefits for patients with glioblastoma multiforme, an especially fatal tumor.

Company officials said the trial, which would target newly diagnosed patients, would begin enrolling patients soon and would have full results in 2014. Meanwhile, earlier data looked promising enough to help patients now, especially with few other treatments available.

"We're confident that we have met the criteria for accelerated approval," said David Schenkein, senior vice president for cancer products at Genentech, which saw U.S. net sales of $2.7 billion from Avastin in 2008.

Glioblastoma has seen renewed public attention since Senator Edward Kennedy was diagnosed with the malignant tumor last year. It is one of the deadliest types of cancer, with patients surviving six to 12 months after diagnosis on average, or six months without treatment.

About 10,000 patients are diagnosed with the disease each year, Genentech said citing the American Cancer Society.

At the meeting, cancer advocates cheered the panel's vote after more than a dozen testified in support of approval.

Avastin patient Gail McWilliams, who lived several years after her diagnosis, said the injectable drug "was a blessing to me ... I feel like the luckiest person on earth."

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