US expands scope of BI’s lung cancer drug Gilotrif

US regulators have approved a supplemental New Drug Application for Boehringer Ingelheim’s lung cancer drug Gilotrif for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant epidermal growth factor receptor (EGFRs). The new label includes data on three additional EGFR mutations: L861Q, G719X, and S768I, which can be detected by an approved test to determine whether patients are suitable for treatment. Gilotrif (afatinib) is already approved in the US for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, and the drug can also be used to treat patients with squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.