The Food and Drug Administration (FDA) has approved an expanded indication for Gilotrif (afatinib; Boehringer Ingelheim) for 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.

The expanded approval now includes three additional EGFR mutations: L861Q, G719X and S768I. This was supported by pooled durable response data in Gilotrif-treated patients (n=32) with metastatic NSCLC harboring non-resistant EGFR mutations (S768I, L861Q, and/or G719X) other than exon 19 deletions or exon 21 L858R substitutions enrolled in 1 of 3 clinical trials from the LUX-Lung clinical program. All study patients were administered Gilotrif 40mg or 50mg orally once daily. 

Data indicated a confirmed overall response rate of 66% (95% CI: 47, 81), as assessed by an independent radiology review. Of the 21 responders, 52% demonstrated a response duration of ≥12 months and 33% demonstrated a response duration of ≥18 months. Diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, and pruritus were reported as the most frequent adverse reactions. 

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Gilotrif, a tyrosine kinase inhibitor, was initially approved to treat patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test and in 2016 for metastatic, squamous NSCLC progressing after platinum-based chemotherapy.

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