Brain Injury Lawyer Blog

Date: 3/31/2009

WASHINGTON (AP) — Preliminary studies of a blockbuster drug from Roche’s Genentech unit are strong enough to speed up its approval for brain cancer, federal cancer experts said Tuesday.

The company has asked the Food and Drug Administration to approve its blockbuster drug Avastin to treat patients with the deadliest form of brain tumor. The drug is already approved for patients with certain types of lung, breast and colon cancer.

The FDA’s panel of 10 outside experts unanimously voted that preliminary results in brain cancer patients warrant accelerated approval, according to an agency spokeswoman. The accelerated approval designation gives early market access to drugs that show promising early results. Companies must submit follow-up studies to stay on the market.

The FDA is not required to follow the advice of its panel, though it often does.

South San Francisco-based Genentech is now owned by drugmaker Roche, based in Basel, Switzerland.

Heading into the meeting, FDA’s drug reviewers said it was difficult to draw a clear connection between Avastin and tumor shrinkage seen in patient medical scans. Reviewers noted the difficulty of measuring tumor size via medical imaging.

But panelists were won over by two studies from Genentech showing between 20 and 25 percent of cancer patients responded to the treatment. The company also noted that “virtually no improvements have been made since the 1970s” in treatment for the cancer, known medically as recurring glioblastoma multiforme.

Avastin was Genentech’s top-selling product last year with revenue of $2.69 billion. However, sales growth has been slowing.

In the last quarter, U.S. sales of Avastin were $731 million, falling short of Wall Street forecasts for $740 million. Analysts said the drug is likely reaching a saturation point in the market and will need additional FDA approvals to continue growing.

Initially approved in 2004, Avastin was the first drug to fight cancer by choking off blood flow to tumors. Such “targeted therapies” were considered a significant advance beyond chemotherapy.

Copyright 2009 The Associated Press.