Clinical Uses
FDA approved in May 2003 for NSCLC, Gefitinib is currently marketed in over 64 countries.
In June 2005 the FDA withdrew approval for use in new patients due to lack of evidence that it extended life.
In Europe gefitinib is indicated since 2009 in advanced NSCLC in all lines of treatment for patients harbouring EGFR mutations. This label was granted after gefitinib demonstrated as a first line treatment to significantly improve progression-free survival vs. a platinum doublet regime in patients harbouring such mutations. IPASS has been the first of four phase III trials to have confirmed gefitinib superiority in this patient population.
In most of the other countries where gefitinib is currently marketed it is approved for patients with advanced NSCLC who had received at least one previous chemotherapy regime. However, applications to expand its label as a first line treatment in patients harbouring EGFR mutations is currently in process based on the latest scientific evidence. As at August 2012 New Zealand has approved gefitinib as first line treatment for patients with EGFr mutation for naive locally advanced or metastatic, unresectable NSCLC. This publicly funded for an initial 4 month term and renewal if no progression.
While gefitinib has yet to be proven to be effective in other cancers, there is potential for its use in the treatment of other cancers where EGFR overexpression is involved.
(Erlotinib is another EGFR tyrosine kinase inhibitor that has a similar mechanism of action to gefitinib. However, since there is, so far, little evidence that erlotinib is suitable as a first line treatment in NSCLC, it is currently restricted to patients who have previously received at least one chemotherapy regime.)
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