US panel sees brain cancer benefit with Roche drug

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 the particularly deadly disease. 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 definitively show the drug’s benefits for patients with glioblastoma, an especially fatal tumor.

Company officials said that trial 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.

The FDA will weigh the panel’s recommendation when it rules on the new use for Avastin, also known as bevacizumab. A decision is expected by May 5.

WASHINGTON (Reuters)