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These highlights do not include all the information needed to use AFATINIB TABLETS safely and effectively. See full prescribing information for AFATINIB TABLETS. AFATINIB tablets, for oral use Initial U.S. Approval: 2013
Medication labelWhy this: Advisory · dailymed-prescription
Afatinib tablets are 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) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1), Clinical Pharmacology (12.1), Clinical Studies (14.1)]. Limitations of Use: The safety and efficacy of afatinib tablets have not been established in patients whose tumors have resistant EGFR mutations [ see Clinical Studies (14.1)]. Afatinib tablets are indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.
- generic_name
- afatinib
- product_names
- Afatinib
- ndc
- 31722-781, 31722-782, 31722-783, 31722-781-30, 31722-782-30, 31722-783-30
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en