AstraZeneca withdraws Iressa application
AstraZeneca announced this week that it is withdrawing its European marketing authorisation application for gefitinib (Iressa) for the treatment of patients with non-small cell lung cancer (NSCLC).
The announcement follows initial analysis of the Iressa survival evaluation
in lung cancer (ISEL) study. The study, which involved 1,692 patients,
investigated survival benefit of the tyrosine kinase inhibitor gefitinib
250mg daily as a monotherapy in patients with NSCLC who had not responded
to chemotherapy. No increase in survival in the overall population was
seen for gefitinib compared with placebo (median 5.6 months versus 5.1
months, hazard ratio 0.89, P=0.07).
However, AstraZeneca says it remains convinced by the evidence that gefitinib
does benefit NSCLC patients. The trial showed an improvement in response
rate (measured by tumour shrinkage) and time to treatment failure, although
these did not translate into a statistically significant survival benefit.
The company says that consideration will be given to submission of a
new marketing authorisation application after full evaluation of the
ISEL data. The full results are expected to be available in the first
half of this year. AstraZeneca says that it will continue to supply gefitinib
to patients who, in consultation with their doctor, wish to continue
treatment.
Gefitinib was approved in the US last year for the treatment of advanced
NSCLC. The company says that discussions are under way with the Food
and Drug Administration about the drug’s future status. |
The
Pharmaceutical Journal
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