How Does Gefitinib Perform in Clinical Oncology? ?

Gefitinib received FDA approval in 2003 for advanced NSCLC, especially in patients harboring EGFR exon 19 deletions or exon 21 L858R mutations. The landmark IPASS trial revealed that gefitinib significantly prolonged progression-free survival (PFS) compared to chemotherapy (carboplatin plus paclitaxel) in EGFR-mutated NSCLC patients. A randomized Phase II study (N = 221) further demonstrated that daily oral gefitinib (250 mg or 500 mg) improved NSCLC symptoms in 43% and 35% of patients, respectively, with 75% of symptomatic relief occurring within 3 weeks[2]. Partial radiological responses occurred in 12% and 9% of patients, with no statistically significant differences between dosages. This trial confirmed 250 mg as the optimal therapeutic dose, minimizing toxicity while maintaining efficacy.