Roche/Genentech, maker of Avastin (bevacizumab), has requested a hearing before the U.S. Food and Drug Administration to appeal the agency’s December 2010 decision to withdraw approval of bevacizumab as a treatment for metastatic breast cancer.
To build the case for a hearing, the manufacturer must furnish data to FDA demonstrating that the agency’s initial ruling was based on incomplete or inaccurate information. The agency has 60 days from mid-January, or until about March 10, to decide whether to grant a hearing, according to Genentech.
Basis of the Appeal
In its formal hearing request, Genetech argues that post-marketing clinical trials of bevacizumab met their goal of lengthening progression-free survival, or the length of time a cancer does not grow. FDA sets the goals, or endpoints, of clinical trials to be conducted after it grants accelerated approval. Because trials of bevacizumab met the FDA-set endpoint, Genentech suggests, the approval should not be revoked.
The company also argues that revocation sets a precedent that could endanger future cancer research and challenge patient-physician decisionmaking. To address concerns from FDA and advocates, Genentech proposes a double-blinded, randomized, national clinical trial to confirm the progression-free survival benefit of bevacizumab and paclitaxel (Taxol) to paclitaxel alone. Researchers would search for genetic markers to determine which women are most likely to benefit from the treatment.
Next Steps for Bevacizumab
Should FDA revisit its decision, any ruling from a new hearing would be final. With a second rejection, FDA would immediately withdraw bevacizumab from the breast cancer indication. Approvals for other cancers would not be affected, so doctors could continue to prescribe bevacizumab “off label,” or for an unapproved use. Insurers, however, are unlikely to pay for it.
LBBC has learned from several women that their insurance companies will begin denying coverage of bevacizumab as of late January. The Centers for Medicare and Medicaid Services will continue to reimburse for bevacizumab treatment until FDA makes its final ruling.
In response, Genentech encourages women whose metastatic breast cancer is responding to bevacizumab to contact its Access Solutions program at (866) 422-2377. This program helps to offset costs for the company’s medicines. Registrants in the program will be assigned a case manager and be screened for eligibility based on diagnosis, annual income and other factors. Healthcare providers may address questions to the company’s Medical Communciations Group at (800) 821-8590.
After a final negative ruling, Genentech may pursue redress through the U.S. court system. Researchers may continue to conduct clinical trials that study bevacizumab in particular subtypes of metastatic breast cancer, note several members of LBBC’s Medical Advisory Board.
Comment to FDA or LBBC
You may submit a public comment directly to FDA through agency Docket FDA-2010-N-0621. If you would like to share your opinions about or experiences with bevacizumab, we also invite you to write to us at email@example.com. We will post your comments as they are submitted.