Gefitinib

Gefitinib (Iressa, AstraZeneca AB) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: EGFR (1).
Approved indications of Gefitinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
Activating mutations of EGFR-TK
Monotherapy
Any line
advanced
None
Full text of section 4.1 (therapeutic indications)

IRESSA is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).

Label history

18 changes to the Iressa label since 2009, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes