The FDA has approved a supplemental New Drug Application (sNDA) for afatinib for the 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 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.
The sNDA approval is based on a pooled analysis of three studies from the LUX-Lung clinical trial program (phase II LUX-Lung 2 study and phase III 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.
"The approval of [afatinib] as a targeted therapy for these additional non-resistant EGFR mutations significantly alters the treatment strategy for this population," said Edward Kim, MD, Chair of the Department of Solid Tumor Oncology, Levine Cancer Institute, Carolinas HealthCare System.