Genentech has had a lot of good fortune in its dealings with the FDA over the years, but it was dealt a significant setback today.
The South San Francisco-based biotech company, a unit of Switzerland-based Roche, failed to win over an FDA advisory panel that was asked to weigh in on whether bevacizumab (Avastin) should retain its FDA clearance to be sold as a breast cancer treatment. Genentech, over two days of hearings, was seeking to appeal an FDA recommendation from December, in which the agency said clinical trial evidence no longer justifies including breast cancer among the approved uses for the hit antibody drug. The final decision will now be up to FDA commissioner Margaret Hamburg.
“We are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove an important medicine for women with this incurable disease who already have too few treatment options,” Genentech said today in a statement. “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”
Bevacizumab, the first drug shown to fight tumors by cutting off their blood supply, was first cleared by the FDA in 2004 as a therapy for colorectal cancer, and it later went on to win approval for lung, brain, and kidney tumors. While bevacizumab will clearly remain one of the world’s biggest selling drugs for years to come based on its wide usage against various tumors, analysts expect the company could miss out on as much as $1 billion in annual sales by losing clearance for the drug as a breast cancer treatment. Doctors are still free to prescribe the treatment to breast cancer patients, but it may be more difficult to secure insurance reimbursement without breast cancer data included in the FDA-cleared prescribing information. For now at least, the prescribing information still includes breast cancer as an approved use.
There was a lot of real-time tweeting emerging over the past couple days from this hearing in Silver Spring, MD, and quite a few stories summing up the action. For more on yesterday’s testimony, check this piece from the New York Times. For a quick summary of today’s highlights, check this account from CNN and another from the Wall Street Journal.
