FDA accepts sNDA for Gilotrif (afatinib) in metastatic non-small cell lung cancer with EGFR, exon 21 (L861Q), G719X or S768I substitution mutations.- Boehringer.

Boehringer announced that the supplemental New Drug Application (sNDA) for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by the FDA. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors 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 tumors 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.

The submission is based on a meta-analysis of three clinical trials from the LUX-Lung clinical trial program that examined the efficacy of Gilotrif in patients whose tumors have uncommon EGFR mutations. The efficacy outcomes evaluated in the study included: objective response, disease control, duration of response, progression-free survival and overall survival. Uncommon mutations, which include L861Q, G719X or S7681, represent less than 10 percent of the EGFR mutations found in NSCLC patients and are associated with poor prognosis and survival.

Comment: If approved for this additional indication, Gilotrif would offer one of the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC.