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.
“With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations,” said Sabine Luik, senior vice president of Medicine & Regulatory Affairs, at Boehringer Ingelheim Pharmaceuticals.
“Compared with other EGFR mutations, L861Q, G719X or S768I substitution mutations are associated with a poorer prognosis and limited treatment options,” added Edward Kim, Levine Cancer Institute, Carolinas HealthCare System.
“The approval of Gilotrif as a targeted therapy for these additional non-resistant EGFR mutations significantly alters the treatment strategy for this population.”