FDA Expands Gilotrif Indication for Non–Small-Cell Lung Cancer

New label includes data on three additional EGFR mutations: L861Q, G719X, and S768I

The FDA has approved a supplemental new drug application (sNDA) for afatinib (Gilotrif, Boehringer Ingelheim) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X, and S768I.

The FDA granted priority review status to afatinib in evaluating this application.

Afatinib, an oral, once-daily tablet, was previously approved in the U.S. for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. In addition, afatinib is approved in the U.S. for patients with squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

The sNDA approval is based on a pooled analysis of three studies from the LUX-Lung clinical trial program (phase 2 LUX-Lung 2 study and phase 3 studies LUX-Lung 3 and LUX-Lung 6) that examined afatinib in NSCLC patients whose tumors have EGFR mutations, including L861Q, G719X, or S768I. This analysis showed that afatinib was active in these EGFR mutations based on objective response rate, duration of response, disease control, progression-free survival, and overall survival.

“Compared with other EGFR mutations, L861Q, G719X, or S768I substitution mutations are associated with a poorer prognosis and limited treatment options,” said Edward Kim, MD, of the Levine Cancer Institute in the Carolinas HealthCare System, in a press release. “The approval of Gilotrif as a targeted therapy for these additional nonresistant EGFR mutations significantly alters the treatment strategy for this population.”

To determine if a patient is eligible for afatinib, physicians must conduct a test for genetic mutations—also known as biomarker testing—to determine the type of EGFR mutation present.

Source: Boehringer Ingelheim; January 16, 2018.