Brain Tumor Action Network

By Jared A. Favole

Source: Dow Jones Newswire

SILVER SPRING, Md. (Dow Jones)–Medical experts Tuesday said positive responses in patients taking Genentech Inc.’s Avastin were sufficient to support approving the drug to treat an aggressive form of brain cancer that affects 10,000 people annually.

A panel of 10 medical experts unanimously agreed that trial results involving Avastin, already approved to treat advanced breast, lung and colorectal cancers, supported granting the drug accelerated approval. The U.S. Food and Drug Administration, which sponsored the panel, will consider the group’s recommendations in deciding whether to approve the drug for patients with glioblastoma multiforme, an aggressive brain cancer with a median survival rate of seven to nine months.

The FDA is scheduled to make a final decision by May 5. Approval would likely boost the already ample sales of Avastin, which brought in $2.7 billion in 2008.

Overall, panel members felt the data presented by Genentech showed the drug was likely to result in either prolonging or improving patients’ lives.

This drug is “substantially better than almost anything else” approved for this disease class in the last 30 years, said Michael Link, a panel member and pediatric oncologist from the Stanford University School of Medicine in California.

Genentech is seeking what is called accelerated approval, under which the FDA allows a drug for serious and life-threatening diseases to go to market so long as it meets certain benchmarks and the company promises to do a post-marketing study to confirm the benefits of the medicine. The FDA is supposed to make a decision on whether to approve the drug by May 5.

The FDA will have to decide whether tumor shrinkage observed in patients who took Avastin are sufficient to support approval.

Genentech said about 28% of patients experienced tumor shrinkage on Avastin, while the FDA said the number was 26%. An important factor for patients with this disease is how long patients experience this tumor shrinkage. The company said most patients experienced this shrinkage for an average of five months.

The panel heard from a variety of people who suffer from glioblastoma multiforme or have family members who do. Lindsay Zortman described how her son, Armstrong, has a tumor that takes up the entire left hemisphere of his brain and has regrown completely in less than three weeks. She pleaded with the panel to approve Avastin.

Panel members said there was a lack of evidence provided to determine whether Avastin actually improved a patient’s quality of life, but agreed the testimony from victims of the disease was compelling. Many said a post-marketing study would help answer those questions. Such a study is required and Genentech and the FDA are working on details of the study, should the drug get approved.

Panel member Frederick Barker, a neurosurgeon at Massachusetts General Hospital, seemed to characterize the sentiments of the panel best when he said he supports the Avastin’s approval based on a “bet” that the post-marketing study will prove it improves or prolongs patients lives.

Despite its wide sales, Avastin has brought some negative attention to Genentech. The drug is expensive. A four-and-a-half month regimen of the drug to treat glioblastoma multiforme costs about $39,600. Genentech will provide the drug to patients for free once they use about $55,000 worth, said Kristina Becker, a company spokeswoman.

Genentech was recently acquired by Swiss pharmaceutical company Roche Holding AG (RHHBY).

-By Jared A. Favole,
Dow Jones Newswires;
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