F.D.A. Grants Hearing on Avastin as Treatment for Breast Cancer
By ANDREW POLLACK

The Food and Drug Administration has granted a hearing for Genentech to argue in favor of preserving the approval of its drug Avastin as a treatment for breast cancer.

The hearing will take place June 28-29, the F.D.A. said in a letter
to Genentech’s lawyer and to a lawyer for the F.D.A.

The F.D.A. announced in December that it planned to revoke the approval of Avastin for breast cancer because new studies did not show the drug was helping women live longer or to delay the progression of their cancers very long, while at the same time exposing them to dangerous side effects. The decision has split the breast cancer community.

While Genentech, a subsidiary of Roche, will get its day in court, so to speak, it will not get the jury it wanted. The hearing will be in front of the F.D.A.’s Oncologic Drugs Advisory Committee. That committee voted 12 to 1 last July that the approval of Avastin for breast cancer should be withdrawn.

In its request for the hearing, Genentech argued that the committee did not have enough breast cancer specialists and therefore could not properly evaluate the importance of Avastin for that disease.

But in her letter to the company’s lawyer, Dr. Karen Midthun, the F.D.A. officer who will oversee the hearing, said she would not add breast cancer experts to the committee. “We must face the reality,’’ she wrote, “that many experts in this area have already expressed a view on this issue and/or might be considered as having conflicts because of their association with one of the parties to the hearing or competitors to Genentech.’’

The letter sets out other ground rules. The first day of the hearing will be devoted to presentations by witnesses chosen by Genentech and by the F.D.A.’s drug division, with each side given equal time. On the second day, the advisory committee will make recommendations.

Members of the public can submit written testimony but will not be allowed to speak at the meeting. The ultimate decision will be made by the F.D.A. commissioner, Dr. Margaret Hamburg.