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Alert for Healthcare
Professionals
Gefitinib (marketed as Iressa)
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.
To report any unexpected adverse or serious events
associated with the use of Elidel, please contact the FDA MedWatch
program at 1-800-FDA-1088 or
http://www.fda.gov/medwatch/report/hcp.htm
Recommendations
Under the Iressa Access Program prescriptions for
Iressa will be limited to the following patient populations:
-
patients currently receiving and benefiting from
Iressa;
-
patients who have previously received and
benefited from Iressa; and
-
previously enrolled patients or new patients in
non-Investigational New Drug (IND) clinical trials approved by an
IRB prior to June 17, 2005.
New patients may also be able to obtain Iressa if
AstraZeneca decides to make it available under IND and the patients
meet the criteria for enrollment under the IND.
Data Summary
Iressa, an orally administered epidermal growth factor receptor (EGFR)
tyrosine kinase inhibitor, was approved for marketing in May 2003
for patients with non-small cell lung cancer (NSCLC) under Subpart H
accelerated approval regulations that allow products to be approved
on the basis of a surrogate endpoint for clinical efficacy. For
Iressa the surrogate end-point was tumor response rate. The response
rate in patients taking the drug was approximately 10%. The approved
indication was for the treatment of patients who were refractory to
established cancer treatments (both a platinum drug and docetaxel).
However, since the initial approval of Iressa, Tarceva (erlotinib)
has been approved for treatment of this same group. Tarceva was
approved based on improved overall survival.
FDA has carefully reviewed data from two failed clinical studies of
Iressa, one of which was required by the agency as part of the
drug’s accelerated approval. This trial enrolled patients with
regionally advanced or metastatic NSCLC who had failed one or two
prior treatment regimens. In this large study, 1,692 patients were
randomized to gefitinib or placebo. There was no significant
survival benefit in the overall study population nor in patients who
had high levels of a surface marker called “EGFR”. In contrast, the
presence of EGFR at high levels appears to predict a good response
to Tarceva.
In the second trial in patients with stage III NSCLC, after
completion of induction and consolidation chemotherapy and radiation
therapy, patients were randomized to Iressa or placebo maintenance
therapy. No Iressa survival benefit could be demonstrated.
The Food and Drug Administration is not considering market
withdrawal of Iressa at this time. New clinical trials are being
developed, other ongoing trials are being completed, and there will
be further analysis of the completed trials described above. These
will determine the future role of Iressa treatment.
FDA Patient Information Sheet
http://www.fda.gov/cder/drug/infosheets/patient/gefitinibPIS.pdf
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov
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Date created: June 17, 2005 |
