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FDA ALERT [6/2005]:
FDA has approved new labeling for gefitinib (Iressa)
that limits the indication to cancer patients who, in the
opinion of their treating physician, are currently
benefiting, or have previously benefited, from Iressa
treatment. AstraZeneca plans to limit distribution of this
drug under a risk management plan called the Iressa Access
Program.
This
information reflects FDA?s preliminary analysis of data
concerning this drug. FDA is considering, but has not
reached a final conclusion about, this information. FDA
intends to update this sheet when additional information or
analyses become available. |
Wednesday 22nd December, 2004
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A large clinical trial comparing Iressa (gefitinib) with placebo in patients
with non-small cell lung cancer showed no survival benefit from taking Iressa.
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The FDA today released the following statement regarding the failure
of a clinical trial of Iressa (gefitinib) to show an overall survival
advantage in treating patients with lung cancer:
The Food and Drug Administration (FDA) learned yesterday from
AstraZeneca that a large clinical trial comparing Iressa (gefitinib)
with placebo in patients with non-small cell lung cancer who had failed
other courses of cancer therapy showed no survival benefit from taking Iressa.
Patients currently taking Iressa should consult with their physicians
as soon as possible; patients should not change their therapy without
first consulting with their physicians.
Alternative therapies are available. FDA has approved Taxotere (docetaxel)
and Tarceva (erlotinib), both of which have been shown in studies to
improve survival in patients with non-small cell lung cancer whose
cancer has progressed while on previous therapies.
FDA approved Iressa on May 2, 2003, under the Agency's accelerated
approval (Subpart H) program, for the treatment of patients with
non-small cell lung cancer who had failed two or more courses of
chemotherapy. The accelerated approval provisions in FDA's regulations
allow the agency to approve a drug for marketing based on an effect on a
surrogate endpoint -- such as a sign of a disease or the results of a
laboratory test -- that is considered reasonably likely to predict
clinical benefit (improved symptoms or survival). Iressa was approved
because the data from clinical trials showed that it caused significant
shrinkage in tumors in about 10% of patients, and this was thought
likely to increase patients' overall survival time.
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One requirement for drugs approved under the agency's accelerated
approval program is that the sponsor must study them further after
approval to verify the expected clinical benefit. After the approval of
Iressa in 2003, AstraZeneca conducted a study in approximately 1700
patients to determine whether the drug would in fact prolong survival in
comparison to patients taking placebo. The results announced today
indicate that the drug did not prolong survival. Under FDA's accelerated
approval program, the Agency has the authority to remove a drug from the
market if a postmarketing clinical study fails to verify clinical
benefit. After FDA has evaluated the recent study results, FDA will
determine whether Iressa should be withdrawn from the market or if other
regulatory actions are appropriate.
Source
Food and Drug Adminstration.
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