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FDA grants priority review to Gilotrif for advanced lung cancer with uncommon EGFR mutations
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The FDA granted priority review to a supplemental new drug application that seeks approval of afatinib for first-line treatment of certain patients with metastatic non-small cell lung cancer.
The designation applies to use of afatinib (Gilotrif, Boehringer Ingelheim) — an epidermal growth factor receptor tyrosine kinase inhibitor — for patients with EGFR mutations in exon 21 (L861Q), G719X or S768I as detected by an FDA-approved test.
These mutations — which account for less than 10% of EGFR mutations found in NSCLC — are associated with poor prognosis. No targeted therapies are available for patients with these mutations.
“The acceptance of the supplemental new drug application filing with priority review recognizes our company’s ongoing commitment to further study Gilotrif in areas of high unmet medical need for patients with few treatment options,” Martina Flammer, MD, vice president of clinical development and medical affairs specialty care at Boehringer Ingelheim Pharmaceuticals, said in a company-issued press release. “If approved for this additional indication, Gilotrif would offer the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC.”
The FDA based the priority review designation on results of a meta-analysis of three phase 3 trials from the LUX-Lung clinical trial program.
The studies assessed afatinib in patients with NSCLC whose tumors harbor EGFR mutations in L861Q, G719X or S768I. Efficacy outcomes included OS, PFS, objective response, duration of response and disease control.
The FDA previously approved afatinib for first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 mutations, as well as for treatment of patients with squamous cell carcinoma of the lung whose disease progressed after platinum-based chemotherapy.