UPDATE 12/6: FDA held a public teleconference on Thursday, December 16. To listen to a recording, dial (866) 357-4215; international callers can dial (203)369-0130. The passcode is 121610. The program lasts about an hour.
In 2008, FDA granted accelerated approval to bevacizumab as initial treatment for HER2 negative metastatic breast cancer. The approval was based on preliminary findings from the E-2100 clinical trial that showed increased progression-free survival among women who added bevacizumab to paclitaxel (Taxol) chemotherapy.
The subsequent studies AVADO and RIBBON-1 failed to confirm an overall survival benefit, and participants did not live as long without progression of disease as they had in E-2100. In addition, some women had severe side effects that contributed to FDA’s overall appraisal that the benefits of bevacizumab do not outweigh its risks.
Roche/Genentech, the manufacturer of bevacizumab, plans to appeal FDA’s decision. During the appeal process, bevacizumab remains available as a treatment for metastatic breast cancer.
Today’s action by the FDA is only the first step in a months-long review process. In the meantime, bevacizumab remains an approved first-line treatment for HER2 negative metastatic breast cancer. During this time the Centers for Medicare and Medicaid Services will continue to reimburse for bevacizumab treatment, which suggests private insurance companies will continue covering the costs as well.
If you are currently taking bevacizumab, your doctors can continue to make medical judgments about whether this medicine is an appropriate treatment for you. If you have concerns about bevacizumab or its side effects, we encourage you to speak with your healthcare team.
In a conference call with breast cancer advocates, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said she and her colleagues support efforts to clarify the effectiveness of bevacizumab in breast cancer. She encouraged Roche/Genentech, the manufacturer, to “conduct additional [clinical trials] to identify if there may be select groups of patients who might benefit from this drug.”
If you have questions or concerns about insurance coverage, you may call the manufacturer’s Access Solutions Group toll-free at (866) 422-2377. Healthcare providers can address questions to Genentech’s Medical Communciations Group at (800) 821-8590. Find out about Living Beyond Breast Cancer's perspective in our statement on Avastin.
After issuing its decision, FDA took the unusual step of issuing a Notice of Opportunity for a Hearing, a regulatory process that allows manufacturers to appeal FDA decisions. The NOOH gives Genentech 15 days, until December 31, to request a public hearing. Genentech must prove to FDA that its initial review was based on incomplete or inaccurate information. The company then has 15 more days to submit materials to FDA for the hearing.
Genentech announced this afternoon its intention to appeal the ruling. If FDA grants a hearing, the date and time will be published in the Federal Register. Agency officials said a decision would not be made at the hearing, but a final written decision would be issued at the conclusion of the process. Should FDA uphold its ruling, Genentech could seek redress through the U.S. court system.
As part of the review process, you may submit public comments. You may send them to Living Beyond Breast Cancer at firstname.lastname@example.org or submit them directly to FDA through agency Docket FDA-2010-N-0621. LBBC will post comments from women and providers on lbbc.org and submit them to FDA by the deadline.