WASHINGTON, Feb. 25 (UPI) -- The U.S. Food and Drug Administration says Genentech will get a hearing to argue for keeping the approval of its drug Avastin as a treatment for breast cancer.
The FDA said in December it planned to revoke the approval of Avastin for breast cancer as new studies suggested the drug was not improving the survival rate for women with breast cancer while at the same time exposing them to dangerous side effects, The New York Times reported Friday.
The hearing for Genentech, a subsidiary of Roche, will be held June 28-29 in front of the FDA's Oncologic Drugs Advisory Committee, the same committee that voted 12 to 1 last July to strip Avastin's approval as a breast cancer drug.
Genentech said the committee did not include enough breast cancer specialists and could not properly judge the importance of Avastin for the disease.
In a letter to the company, Dr. Karen Midthun, the FDA 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."
At the hearing there will be presentations by witnesses chosen by Genentech and by the FDA's drug division, with each side given equal time.
The advisory committee will then make recommendations, and the ultimate decision will be made by FDA Commissioner Margaret Hamburg, the Times reported.
