The US Food and Drug Administration (FDA) has agreed to hold a two-day hearing to give Genentech an opportunity to convince the agency not to revoke Avastin's (bevacizumab's) indication in breast cancer. Controversy raged among patients, medical professionals, and politicians from the moment the FDA announced last year that it was considering withdrawing its approval of Avastin to treat metastatic breast cancer.
Approval had been granted on an accelerated basis, with full approval pending additional confirmatory data. In a 12-to-1 decision, an Oncologic Drugs Advisory Committee (ODAC) concurred with the FDA that follow-up studies failed to show enough improvement in overall survival or progression-free survival for patients with breast cancer to justify the risks associated with the drug.
Genentech criticized the makeup of the ODAC panel as having too few breast cancer experts to make an informed decision. Following the FDA's announcement, the company requested a hearing before a new panel.
In a letter to Genentech's lawyers, dated February 23, 2011, Dr Karen Midthun, the FDA officer overseeing the hearing, said the agency is using the same panel but will allow Genentech to present its own experts on day one of the hearing. Witnesses testifying on behalf of the Center for Drug Evaluation and Research (CDER) will receive equal time. The public has been invited to submit written testimony. On day two of the hearing, the ODAC panel will present its conclusions. FDA commissioner Dr Margaret Hamburg will make the final ruling.
Prior to the hearing, Midthun wants Genentech and CDER to outline all disputed issues in a joint statement and submit this list to the FDA in mid-March. By April 20, 2011, each side must provide a summary of their respective arguments and evidence to the FDA. Midthun said all documents and testimony available to the public.
The United Kingdom's National Institute for Health and Clinical Excellence declined today to approve Avastin for metastatic breast cancer. The regulatory agency said evidence for the drug's effectiveness in improving overall survival "was not robust" and concluded that the drug was not cost-effective.
