THURSDAY, Dec. 16 (HealthDay News) -- Federal health officials
on Thursday recommended revoking approval of the drug Avastin to
fight breast cancer, citing the medication's poor performance in
follow-up studies and its potential for serious side effects.
But the recommendation, announced by U.S. Food and Drug
Administration (FDA) officials at a news conference, will not
immediately affect breast cancer patients' access to the drug or
limit use of the Avastin (bevacizumab) for advanced colon, lung,
kidney and brain cancer.
Nevertheless, the decision could leave breast cancer patients
who have responded well to the drug wondering what to do next.
"FDA has taken the first step to removing the breast cancer indication from the label of the cancer drug Avastin," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), announced at the news conference. "This is a first step in a process and will not have an immediate impact on use of Avastin or the drug's availability."
"Oncologists currently treating patients with Avastin should use medical judgment in deciding whether to continue treatment or explore other treatment options," she added.
The drug's maker, Genentech, has been notified of the
recommendation in writing and now has 15 days to request a
proceeding to dispute the FDA recommendation and present additional
evidence. The company "has not agreed to remove the breast cancer
indication voluntarily," the FDA noted in a statement released
Some doctors expressed concern at the decision.
"This is a tough issue. There are women who have clearly responded to the treatment, [and] this is going to be a very difficult pill to swallow for those women," said Dr. Neil Spector, professor of medicine at Duke Cancer Institute in Durham, N.C.
"There's a very real possibility that there may be a subgroup of women that are likely to respond to this," Spector said. "I don't think this will be the end from the standpoint of investigation and people trying to understand who that subpopulation is. It's just unfortunate that this will put a huge crimp in trying to figure that out."
Another expert, Dr. Julie Gralow, director of breast medical
oncology at the Seattle Cancer Care Alliance (SCCA), called the FDA
"It is clear that some breast cancer patients derive substantial benefit from Avastin," Gralow, who is also professor in the Medical Oncology Division of the University of Washington School of Medicine, said in a SCAA press statement. "We don't know how to select those tumors or patients yet. It is looking like patient factors, not tumor factors, might be the best way to select those who benefit. To withhold this drug from all patients because some don't benefit is incorrect."
Doctors can continue to prescribe Avastin to patients
"off-label," as they do other drugs. But it's unlikely that
insurance companies will cover off-label use of the drug given its
high price tag, Spector said. Avastin now costs more than $8,000 a
month, according to published reports.
The FDA did not rule out the possibility that if Avastin is
actually revoked, approval could be restored for certain subgroups
of patients who may benefit.
"FDA is ready to work with Genentech on any proposals to conduct additional studies in metastatic breast cancer designed to identify responsive tumors," added Woodcock.
In making the announcement, the FDA predictably followed the
recommendation of an advisory panel, which voted 12 to 1 last July
to strike breast cancer from the approved uses listed on the
Avastin was okayed in 2008 for use in conjunction with
chemotherapy under the FDA's accelerated approval program. Approval
was based on one clinical trial in patients with metastatic
HER2-negative breast cancer that found a benefit in terms of cancer
recurrence -- but not overall survival -- and was contingent on
further data to confirm the results.
Three subsequent studies failed to find an overall survival
benefit and, in fact, showed less impressive improvements in
survival involving no progression of cancer.
After reviewing all four studies, FDA concluded that "patients
receiving Avastin did not live any longer than patients not treated
with the drug and were at greater risk of severe side effects, some
of which are unique to Avastin," Woodcock said.
"These include perforations of the nose, stomach and intestine, many of which can be life-threatening, as well as high blood pressure, heart attack or heart failure, wound-healing complications and organ damage or failure," she said.
The U.S. National Cancer Institute has more on
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