Was the accelerated approval for bevacizumab(Drug information on bevacizumab) in this setting inappropriate? No, according to the experts who spoke with Oncology News International. And it's not surprising that just as data can change over time, approval status may also shift.
ERIC WINER, MD
"The approval process doesn't have to be so conservative, and it can be flexible as the data mature," said Eric Winer, MD, professor of medicine at Harvard Medical School and chief of women's cancer at Dana-Farber Cancer Institute, both in Boston. "That is a good thing. I agree with the concept that data can evolve over time and what looks like a good choice in one year may look unfavorable in another year."
While the three studies do not show survival benefits, bevacizumab does appear to help a subset of women who may end up living longer, Dr. Winer said.
"My own preference is to have it for some patients. It should not disappear from our armamentarium," said Dr. Winer, adding that the agent does improve PFS by a small to moderate amount and helps to control cancer.
SARA HURVITZ, MD
"I think PFS is enough to get accelerated approval of the drug so it was appropriate to approve it. However, survival does remain the gold standard," said Sara Hurvitz, MD, an assistant professor of medicine and director of the breast oncology program at the University of California, Los Angeles, Jonsson Comprehensive Cancer Center
Nonetheless, Dr. Hurvitz said she hopes that women who are currently on bevacizumab, and benefiting from it, will not see an interruption in their therapy.
Obviously, neither patients nor their physicians can make any significant decisions until the FDA renders its verdict. Assuming the FDA takes the panel's advice, bevacizumab will remain on the market as an approved treatment option for colon, lung, kidney, and brain cancers (see Related Reading). While physicians could still prescribe bevacizumab for breast cancer patients as an off-label drug, obtaining reimbursement could be problematic. As an approved drug, Roche/Genentech capped yearly spending on Avastin at $57,000 for patients with incomes below $100,000. Without this cap, the wholesale price of bevacizumab could be $88,000 per breast cancer patient (New York Times, July 20, 2010).
CHARLES SHAPIRO, MD
During an interview conducted in August, Charles Shapiro, MD, director of breast medical oncology at Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus, recommended that patients should not be started on bevacizumab unless they are in a clinical trial.
"Those who are benefiting are now in a bad situation, and I think special arrangements need to be made so that patients don't have to pay. We will have to see what happens, but I would make a plea to insurance companies that any patient who is responding to bevacizumab should remain on it," said Dr. Shapiro, who is also a professor of medicine at the university.
He said that ongoing clinical trials of bevacizumab in the adjuvant setting may turn in different results (see Table). Roche/Genentech said there are no plans to alter or stop the trials that are underway. However, the question remains: Will patients not in clinical trials be forced off the medication if the FDA rescinds the approval?
"It is a little early to be asking these questions," said Charlotte Arnold, a spokesperson for Roche/Genentech. "We understand that there are a lot of concerned people out there."