Health Vidya

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.