U.S. panel sees brain cancer benefit with Roche drug

By Susan Heavey

WASHINGTON (Reuters) - Early data for Roche Holding AG's 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."

While the FDA does not weigh costs when approving products, many insurers decide whether to pay for certain uses of medication based on FDA clearance.

Genentech spokeswoman Kristina Becker said the estimated cost for a course of Avastin for brain cancer would be $39,600, adding that programs are available to help with costs.

FDA staff reviewers expressed some concern about whether the magnetic resonance images used to measure patients' tumors was reliable. They also questioned whether Avastin was causing patient's response or whether some other factor was at play.

Several panelists also said they wanted to see more safety data. The most common side effects were fatigue, headache and hypertension, according to the FDA's analysis.