For Immediate Release: Nov. 18,
2011 FDA Commissioner Margaret A. Hamburg, M.D.,
said today she is revoking the agency’s approval of the breast cancer indication
for Avastin (bevacizumab) after concluding that the drug has not been shown to
be safe and effective for that use.
Avastin will still remain on the market as
an approved treatment for certain types of colon, lung, kidney and brain cancer
(glioblastoma multiforme).
“This was a difficult decision. FDA
recognizes how hard it is for patients and their families to cope with
metastatic breast cancer and how great a need there is for more effective
treatments. But patients must have confidence that the drugs they take are both
safe and effective for their intended use,” Dr. Hamburg said. “After reviewing
the available studies it is clear that women who take Avastin for metastatic
breast cancer risk potentially life-threatening side effects without proof that
the use of Avastin will provide a benefit, in terms of delay in tumor growth,
that would justify those risks. Nor is there evidence that use of Avastin will
either help them live longer or improve their quality of life.”
Avastin’s risks include severe high blood
pressure; bleeding and hemorrhaging; heart attack or heart failure; and the
development of perforations in different parts of the body such as the nose,
stomach, and intestines.
Today’s decision, outlined in Dr Hamburg’s
69-page opinion, involves Avastin used in combination with the cancer drug
paclitaxel for those patients who have not been treated with chemotherapy for
their form of metastatic breast cancer known as HER2 negative. This indication
must now be removed from Avastin’s product labeling.
Dr. Hamburg’s decision is based on an
extensive record, which includes thousands of pages submitted to a public
docket, data from several clinical trials and the record from a two-day hearing
held in June, 2011.
Avastin was approved for metastatic breast
cancer in February 2008 under the FDA’s accelerated approval program, which
allows a drug to be approved based on data that are not sufficiently complete to
permit full approval. The accelerated approval program provides earlier patient
access to promising new drugs to treat serious or life-threatening conditions
while confirmatory clinical trials are conducted. If the clinical trials do not
justify the continued approval of the drug or a specific drug indication, the
agency may revoke its approval. In this case, the accelerated approval was based
on promising results from one study that suggested that the drug could provide a
meaningful increase in the amount of time from when treatment is started until
the tumor grows or the death of the patient.
After the accelerated approval of Avastin
for breast cancer, the drug’s sponsor, Genentech, completed two additional
clinical trials and submitted the data from those studies to the FDA. These data
showed only a small effect on tumor growth without evidence that patients lived
any longer or had a better quality of life compared to taking standard
chemotherapy alone – not enough to outweigh the risk of taking the drug.
FDA’s Center for Drug Evaluation and
Research, which is responsible for the approval of this drug, ultimately
concluded that the results of these additional studies did not justify continued
approval and notified Genentech it was proposing to withdraw approval of the
indication.
Genentech did not agree with the Center’s
evaluation of the data and, following the procedures set out in FDA regulations,
requested a hearing on the Center’s withdrawal proposal, with a decision to be
made by the Commissioner. That two-day hearing, which took place June 28-29,
2011, included recommendations from the FDA's Oncologic Drugs Advisory Committee
(ODAC), voting 6-0 in favor of withdrawing approval of Avastin’s breast cancer
indication. After the hearing, the public docket remained open until Aug. 4,
2011. (In an earlier meeting of the ODAC, that committee had voted 12-1 in favor
of the removal of the breast cancer indication from the Avastin label).
“FDA is committed to working with sponsors
to bring promising cancer drugs to market as quickly as possible using tools
like accelerated approval,” Dr. Hamburg said. “I encourage Genentech to consider
additional studies to identify if there are select subgroups of women suffering
from breast cancer who might benefit from this drug.”
For more information:
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA
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