Research & Development
Boehringer announces expanded indication for Gilotrif for NSCLC patients whose tumors have certain EGFR mutations
17 January 2018 -

Pharmaceutical company Boehringer Ingelheim reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for supplemental New Drug Application (sNDA) for oral, once-daily tablet Gilotrif for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC), the most common form of lung cancer.

The company said the US FDA has approved the supplemental New Drug Application (sNDA) for Gilotrif (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 US FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I.

In conjunction with the Gilotrif application, the company has passed the US FDA's priority review status for evaluating this application.

This sNDA approval is based on the company's pooled analysis of three studies from the LUX-Lung clinical trial programme (Phase II LUX-Lung 2 study and Phase III studies LUX-Lung 3 and LUX-Lung 6) that examined Gilotrif in NSCLC patients whose tumors have EGFR mutations, including L861Q, G719X or S768I.

According to the analysis, Gilotrif was active in these EGFR mutations based on objective response rate, duration of response, disease control, progression-free survival as well as overall survival.

Concurrently, the physicians must conduct a test for genetic mutations – also known as biomarker testing – to determine the type of EGFR mutation present in a patient eligible for Gilotrif, concluded the company.

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