Gefitinib
The lung-cancer pill whose dramatic responses in a few patients led to the discovery of EGFR mutations in 2004.
Accelerated approval 2003 in unselected NSCLC; ISEL (2005) failed and US use was restricted. Lynch and Paez (2004) found EGFR mutations in responders; IPASS (2009) proved mutation-selected first-line superiority over chemotherapy. Re-approved in the US in 2015 for EGFR-mutant NSCLC.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Generic gefitinib is available.
- Commercial insurance
- covered on label
Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- Untreated EGFR mutation-positive NSCLC
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA192 · SMC advice: gefitinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2003 | NSCLC after chemotherapy (accelerated; restricted 2005) |
| EU | 2009 | EGFR-mutant NSCLC |
| US | 2015 | First-line NSCLC with EGFR exon 19 del or L858R |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Gefitinib" OR ABSTRACT:"Gefitinib" OR TITLE:"Iressa" OR ABSTRACT:"Iressa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gefitinib, not a curated reading list.