FDA Approves Expanded Indication for Gilotrif in NSCLC

New labeling includes data on three additional EGFR mutations
New labeling includes data on three additional EGFR mutations

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.

For more information call (800) 542-6257 or visit Gilotrif.com.