In a move that should surprise no one, the National Comprehensive Cancer Network’s panel of breast cancer experts has voted 24-0-1 to stand by its endorsement of bevacizumab (Avastin) for metastatic breast cancer.
The unanimous vote echoes the position taken by panel at the NCCN’s annual conference earlier this year. “The data observed in the [E2100 trial] really had not changed from its approval previously, and we thought that if the data were compelling 2 years ago, why isn’t it compelling enough today?” panel chair Dr. Robert W. Carlson of Stanford (Calif.) University said at that time.
The new endorsement is not the strongest, with an evidence designation of 2A, but the expert panel called bevacizumab in combination with paclitaxel “an appropriate therapeutic option for metastatic breast cancer.”
The panel conveyed its thinking in the following footnote:
“Randomized clinical trials in metastatic breast cancer document that the addition of bevacizumab to some first- or second-line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time to progression impact may vary among cytotoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel.”
The unanimity of NCCN panel’s stance – in direct opposition to the unanimity of the Food and Drug Administration’s Oncologic Drugs Advisory Committee’s 6-0 vote in favor of withdrawing Avastin’s indication for metastatic breast cancer does raise the question of how the proposed withdrawal is viewed by breast cancer experts.
But breast specialists were in short supply on the pared-down advisory committee — a reality noted in a joint comment by Dr. Howard A. Burris III, editor of The Oncology Report, and associate editors Dr. Hope S. Rugo and Dr. William J. Gradishar. In the comment, posted online in advance of print publication, the three oncologists wonder whether “FDA Commissioner [Dr. Margaret] Hamburg is able to hear through the noise and reach a compromise that will be the best for our patients.”
The Pink Sheet, a sister publication of The Oncology Report, tallied 34 speakers in the public portion of last month’s sturm-und-drang hearing — 4 favoring withdrawal, 22 against, 1 defending the pivotal Eastern Cooperative Oncology Group E2100 study, 1 calling for better collaboration on breast biomarker research, and 6 “who generally opposed withdrawing the [metastatic breast cancer] claim but spoke primarily to express concerns about FDA approval standards and the potential impact a withdrawal decision could have on development and approval of oncology treatments in settings beyond breast cancer.”
Public comments on the proposed withdrawal were due to close today, July 28. It will be interesting to see how comments stack up after the mishmash that came in on Medicare’s deliberations over coverage for the prostate cancer drug Provenge.
Meanwhile, the dueling parties — Genentech, Inc. and the FDA’s Center for Drug Evaluation and Research — have been granted an extra week until Aug. 4 for their post-hearing submissions. Considering the current stalemate in Congress, one can only wonder whether there will be anyone at the FDA to read them.
— Jane Salodof MacNeil