OnCo
drugsProductNot mapped hereapproved

Erlotinib

Erlotinib was one of the first EGFR pills for lung cancer; it was approved before anyone knew EGFR mutations predicted who would respond, then redefined by them.

BR.21 (2005): survival benefit in unselected pretreated NSCLC. EURTAC (2012) and OPTIMAL established first-line use in EGFR-mutant disease; osimertinib (FLAURA) later displaced it. Also approved with gemcitabine in pancreatic cancer (marginal benefit). Rash and diarrhoea.

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Erlotinib
PubChem
Modality
Small-molecule EGFR TKI (first generation, reversible)
Mechanism
Reversible ATP-competitive inhibitor of EGFR kinase; most active against exon 19 deletion and L858R mutations.
Brand / code
Tarceva
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 erlotinib is inexpensive.

Commercial insurance
covered on label

Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest. Some plans still require EGFR mutation documentation.

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.

NICE recommendedNICE TA258 · 2012SMC: accepted
Appraised for
Untreated EGFR mutation-positive NSCLC
Notes
Second-line NSCLC: TA162 (2008).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA258 · SMC advice: erlotinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2004Locally advanced/metastatic NSCLC after chemotherapy
US2005Pancreatic cancer with gemcitabine
US2013First-line NSCLC with EGFR exon 19 del or L858R

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
602 studies1 recruiting88 Phase 214 Phase 3
Search “Erlotinib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Erlotinib
intervention: Erlotinib
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Erlotinib" OR ABSTRACT:"Erlotinib" OR TITLE:"Tarceva" OR ABSTRACT:"Tarceva") 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 Erlotinib, not a curated reading list.

Connected

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