Sign Out
APO-GEFITINIB (gefitinib) is indicated for the first-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the EGFR-TK (see Monitoring and Laboratory Tests under Precautions).
This indication was based on progression-free survival (PFS). After 78% of trial patients had died, no statistically significant difference in overall survival (OS) was demonstrated with first-line gefitinib compared to the first-line chemotherapy doublet in patients with EGFR mutation positive tumours in the IPASS study (see Pharmacology: Clinical Trials under Actions).
Geriatrics (≥65 years of age): No differences in safety or efficacy were observed between younger and older patients (see Use in the Elderly under Precautions).
Paediatrics (≤16 years of age): APO-GEFITINIB is not indicated for use in paediatric patients, as safety and effectiveness have not been established (see Use in Children under Precautions).
