Roche’s Avastin Backed by U.S. Panel for Brain Cancer

Roche Holding AG won the backing of a U.S. panel to expand use of the blockbuster drug Avastin, acquired with the purchase last week of Genentech Inc., to patients with a deadly form of brain cancer.

Outside advisers to the U.S. Food and Drug Administration voted 10-0 today in Silver Spring, Maryland, to recommend the medicine be approved for the treatment of glioblastoma multiforme, an incurable brain cancer. About 10,000 Americans are diagnosed with the disease each year, Genentech has said.

If approved, Avastin would be the first new drug cleared for relapsed brain tumors in more than a decade, Roche said previously. The Basel, Switzerland-based company said it will conduct a large study that aims to capture more definitive data on the drug’s benefits. That helped cement the panel’s endorsement of the new use and speeding up the approval process.

“My vote is a bet on the success of the randomized trial that is planned,” said Frederick Barker, associate visiting neurosurgeon of the Massachusetts General Hospital in Boston and a member of the Oncologic Drugs Advisory Committee.

U.S. regulators are expected to rule by May 5, said Kristina Becker, a spokeswoman for Roche’s Genentech, in a telephone interview. The company markets Avastin for advanced cancers of the colon, lung and breast.

FDA staff, conducting a review in advance of today’s meeting, had questioned whether brain scans used by Roche’s Genentech were enough to show Avastin slowed tumor progression.

Stable Tumor

The panel’s vote followed a morning presentation of company data and an afternoon of testimony from patients with brain cancer, their families and advocates.

“If it wasn’t for Avastin, I wouldn’t be here today,” said Richard Oropeza Jr. of Williamsburg, Virginia, a retired program manager for the U.S. Navy, in testimony before the panel. Diagnosed in February 2006, he was given nine to 12 months to live. Now that he’s receiving Avastin infusions, his tumor is stable and not growing, said his wife, Ann Levy- Oropeza. “Thanks for giving us hope,” she said.

David Schenkein, senior vice president of clinical oncology and hematology at Roche’s Genentech unit, argued in his statement to panel members that the tumor shrinkage documented so far with Avastin “may predict overall survival” in the larger study that will start this year and end in 2014.

The FDA often follows the advice of its advisory panels, although it isn’t obligated to do so.

New Mechanism

Avastin was the first of a class of new treatments that work by blocking growth of blood vessels that feed tumor growth. It is approved to treat advanced colon, breast and lung cancers at a wholesale cost of $52,800 a year. Avastin was Genentech’s top-selling product in the U.S. in 2008, with revenue of $2.69 billion. Swiss parent Roche, which owned 56 percent of Genentech before last week’s deal, reported 2008 global sales of 5.21 billion Swiss francs ($4.82 billion).

Avastin’s brain cancer niche isn’t expected to add greatly to Roche’s bottom line, said Deutsche Bank analyst Mark Schoenebaum in an e-mail. He estimated $200 million in annual sales.

Roche rose 5.2 Swiss francs, or 3.4 percent, to 156.2 francs in Zurich trading before today’s vote. Genentech shares ceased trading March 26 on the New York Stock Exchange after its $46.8 billion takeover by Roche was completed.

Source : www.bloomberg.com