The FDA has agreed to Genentech’s request to revisit the agency’s decision to withdraw bevacizumab (Avastin) as an approved treatment for HER2 negative metastatic breast cancer. A public hearing is scheduled for June 28-29, and the resultant ruling is final.
Although open to the public, the hearing is a legal case between Genentech, the manufacturer of bevacizumab, and the Center for Drug Evaluation and Research, the division of FDA responsible for the safety of medicines. Witnesses will debate the science behind the clinical research that led to FDA’s initial accelerated approval of bevacizumab, as well as the relevance and scientific merit of follow-up trials.
Because the hearing focuses on existing data, FDA has not invited women affected by breast cancer to testify. Instead, the agency will accept written comments, which become part of the public record of the hearing. You may submit comments directly to FDA through agency Docket FDA-2010-N-0621.
In a press release, Genentech says it plans to argue that women should have continued access to bevacizumab with paclitaxel (Taxol) while the company designs a new study. This confirmatory clinical trial would include developing a test to determine which cancers are most likely to respond to bevacizumab.
Background of Bevacizumab Approval
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 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. In December 2010, the agency moved to revoke the accelerated approval.
How the Ruling Impacts You
Should the judge enforce FDA’s original ruling, the agency would immediately withdraw bevacizumab as an approved treatment for metastatic breast cancer. Researchers may continue to study bevacizumab in clinical trials, especially in certain subtypes of metastatic breast cancer. Approvals for other cancers would not be affected, so doctors could continue to prescribe bevacizumab off label, or for an unapproved use, but insurers are unlikely to pay for it.
If you are taking bevacizumab and the cancer is responding to it, consider calling the Access Solutions program at (866) 422-2377, even if you do not need financial assistance now. This patient access program, funded by Genentech, helps 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.
Genentech may also pursue the case through the U.S. court system. LBBC will keep you updated on this story.