Genentech Gets Hearing on Breast Cancer Drug Avastin
Genentech is getting another chance to convince federal regulators that their Avastin drug is a safe and effective breast cancer treatment.
The drugmaker was asked by the Food and Drug Administration to stop marketing the drug in the U.S. last year.
The hearing is seen as a win for the biotech company. It has been fighting the FDA's decision to remove the breast cancer indication for Avastin.
In a letter sent to Genentech's lawyers on Wednesday, the FDA agreed to give the company a public hearing on the issue at a two-day meeting with outside agency advisers in June.
We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer, said Hal Barron, M.D., chief medical officer and head of Global Product Development. We believe Avastin is an important option for women with this disease and should remain an FDA-approved choice.
Taking away the breast cancer indication would give health insurance companies a reason to deny payment. It also prevents Genentech from marketing the drug for that use.
The initial objection by the FDA sparked the ire of some patient groups and lawmakers who said the agency was attempting to limit patient options.
In a letter, Genentech told the FDA it does not want the agencys cancer advisers to help weigh the case. However, FDA lawyers told the company that it is the only appropriate committee to consider the issue.