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FDA expands approval of Gilotrif for advanced lung cancer with uncommon EGFR mutations

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Edward S. Kim

The FDA expanded the indication of afatinib to include the first-line treatment of patients with non-small cell lung cancer whose tumors have nonresistant epidermal growth factor receptor mutations L861Q, G719X or S768I as detected by an FDA-approved test.

Afatinib (Gilotrif, Boehringer Ingelheim) — an oral, once-daily EGFR tyrosine kinase inhibitor — is indicated for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations and for patients with squamous cell carcinoma of the lung who have disease progression after chemotherapy.

The FDA based the expanded approval on results from the LUX-Lung clinical trial program, which included patients with NSCLC with EGFR mutations, including L861Q, G719X and S768I.

Results showed afatinib improved ORR, duration of response, disease control, PFS and OS among patients with these mutations.

“Compared with other EGFR mutations, L861Q, G719X or S768I substitution mutations are associated with a poorer prognosis and limited treatment options,” Edward S. Kim, MD, chair of solid tumor oncology and investigational therapeutics at Levine Cancer Institute of Carolinas HealthCare System, and a HemOnc Today Editorial Board Member, said in a press release. “The approval of Gilotrif as a targeted therapy for these additional nonresistant EGFR mutations significantly alters the treatment strategy for this population.”

“With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations,” Sabine Luik, MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said in a press release. “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.”

This indication of Afatinib previously received priority review designation.