Drug updated on 11/13/2023

Dosage FormTablet (oral; 20 mg, 30 mg, 40 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies


  • Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
  • Indicated for the treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy.

Product Monograph / Prescribing Information

Document TitleYearSource
Gilotrif (afatinib) Prescribing Information.2022Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clinical Outcomes of Afatinib Versus Osimertinib in Patients With Non-Small Cell Lung Cancer With Uncommon EGFR Mutations: A Pooled Analysis. 2023The Oncologist
Overall survival benefits of first-line treatments for Asian patients with advanced EGFR-Mutated NSCLC harboring L858R mutation: a systematic review and network meta-analysis.2022JTO Clinical and Research Reports
Overall Survival Benefits of First-Line Treatments for Asian Patients with Advanced Epidermal Growth Factor Receptor-Mutated NSCLC Harboring Exon 19 Deletion: A Systematic Review and Network Meta-Analysis2022Cancers
First‐line treatment of advanced epidermal growth factor receptor (EGFR) mutation positive non‐squamous non‐small cell lung cancer.2021Cochrane Database of Systematic Reviews
Efficacy of afatinib in the treatment of patients with non-Small Cell lung cancer and head and neck squamous cell carcinoma: a systematic review and meta-analysis.2021Cancers
Toxicity profile of epidermal growth factor receptor tyrosine kinase inhibitors for patients with lung cancer: a systematic review and network meta-analysis.2021Critical Reviews in Oncology/Hematology
High-dose administration of tyrosine kinase inhibitors to improve clinical benefit: a systematic review.2021Cancer Treatment Reviews
Hepatotoxicity with epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer patients: a network meta-analysis.2021Journal of Clinical Pharmacy and Therapeutics
Impact of dose reduction of afatinib used in patients with non–small cell lung cancer: a systematic review and meta-analysis.2021Frontiers in Pharmacology
Cost‑effectiveness analysis of the first‑line EGFR‑TKIs in patients with non‑small cell lung cancer harbouring EGFR mutations.2020The European Journal of Health Economics
Comparative analysis of first-line treatment regimens for advanced EGFR-mutant non-small cell lung cancer patients with stable brain metastases.2020Annals of Palliative Medicine
Efficacy and safety of first line treatments for patients with advanced epidermal growth factor receptor mutated, non-small cell lung cancer: systematic review and network meta-analysis.2019BMJ
Systematic review and network meta-analysis of first-line therapy for advanced EGFR-positive non-small-cell lung cancer.2019Future Oncology

Clinical Practice Guidelines