10 October 2017 - Submission is based on a meta-analysis of three LUX-Lung Phase III studies that examined Gilotrif (afatinib) in non-small-cell lung cancer patients whose tumours have “uncommon” EGFR mutations: L861Q, G719X or S768I.

Boehringer Ingelheim today announced that the supplemental new drug application for Gilotrif (afatinib) has been accepted for filing and granted priority review by the U.S. FDA. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.

Gilotrif is already approved in the U.S., EU (Giotrif) and many other markets for the first-line treatment of patients with NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) mutations, and squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

Read Boehringer Ingelheim press release