After 2 days of hearings, the Oncologic Drugs Advisory Committee (ODAC) confirmed the US Food and Drug Administration’s (FDA) earlier decision to remove bevacizumab’s (Avastin, Genentech) indication in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer.
Although the committee voted unanimously (6-0) that the drug does not work and is not safe, the FDA has not made a final decision and bevacizumab remains indicated for this use in this population. The FDA will accept public comment through July 28, 2011. If you choose to make an electronic submission, please submit comments identified with Docket No. FDA-2010-N-0621 to Regulations.gov. The Center for Drug Evaluation and Research and Genentech also have until that date to provide additional written submission.
“We are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” said Hal Barron, MD, chief medical officer and head, Global Product Development, Genentech, in the manufacturer’s press release about the hearings. “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”
The FDA has not announced when the Commissioner will make the final decision. Regardless of the decision, bevacizumab will remain on the market and will maintain approval for its indication in metastatic colorectal cancer, metastatic nonsquamous non–small-cell lung cancer, metastatic renal cell carcinoma, and as a second- or third-line treatment for glioblastoma multiforme.
Bevacizumab originally received accelerated approval for this indication, which requires the manufacturer to conduct additional trials to prove efficacy and safety. Unfortunately, subsequent trials did not show a substantial effect on progression-free survival, an effect on overall survival, or a health-related improvement in patient quality of life.