FDA Grants Priority Review to BI's Gilotrif for Uncommon EGFR Mutations in Advanced NSCLC

Boehringer Ingelheim today announced that the supplemental New Drug Application (sNDA) for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.

Gilotrif is already approved in the U.S., EU (Giotrif) and many other markets for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, and squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

“The acceptance of the sNDA 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,” said Martina Flammer, M.D., Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. “If approved for this additional indication, Gilotrif would offer the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC.”

The submission is based on a meta-analysis of three clinical trials from the LUX-Lung clinical trial program that examined the efficacy of Gilotrif in patients whose tumors have uncommon EGFR mutations. The efficacy outcomes evaluated in the study included: objective response, disease control, duration of response, progression-free survival and overall survival.

Uncommon mutations, which include L861Q, G719X or S7681, represent less than 10 percent of the EGFR mutations found in NSCLC patients and are associated with poor prognosis and survival.

Priority Review designation is granted to applications for drugs that the FDA has determined have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions compared to available therapies. Under Priority Review, FDA typically takes action within six months of receiving a supplemental application, rather than 10 months, which is the standard review timeframe.