Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) of its Gilotrif (afatinib) as first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations.
The agency previously approved Gilotrif for the first-line treatment of NSCLC patients whose tumours have exon 21 L858R mutations. The new indication covers L861Q, G719X and S768I EGFR mutations.
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The sNDA included data from the pooled analysis of Phase II LUX-Lung 2 and Phase III LUX-Lung 3 and LUX-Lung 6 studies under the LUX-Lung clinical trial programme in patients with EGFR mutation-positive NSCLC.
Based on objective response rate, disease control, duration of response, overall survival and progression-free survival, the analysis revealed that Gilotrif was active in the L861Q, G719X and S768I mutations.
Boehringer Ingelheim Pharmaceuticals Medicine and Regulatory Affairs senior vice-president Sabine Luik said: “With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations.
“This approval is a result of our company’s commitment to delivering meaningful treatment advances in areas with high unmet medical need and reflects the tireless efforts of physicians, researchers and patients who participated in our studies.”
The FDA has recommended the use of biomarker testing before treatment with Gilotrif to identify the type of EGFR mutation in a patient.
Gilotrif is additionally indicated in the US for the treatment of lung squamous cell carcinoma in patients who have progressed after platinum-based chemotherapy.
