RIDGEFIELD, Conn. — After being granted a priority review from the Food and Drug Administration this past fall, Boehringer Ingelheim Pharmaceuticals Inc. has received approval of its supplemental New Drug Application (sNDA) for Gilotrif (afatinib), a lung cancer medication.

Boehringer Ingelheim said Gilotrif is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I.

An oral, once-daily tablet, Gilotrif was previously approved in the U.S. for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. In addition, Gilotrif is approved in the U.S. for patients with squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

According to Boehringer Ingelheim, Gilotrif now offers the broadest first-line treatment option in EGFR mutation-positive NSCLC.

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

To find out if a patient is eligible for Gilotrif, doctors must conduct a test for genetic mutations, also known as biomarker testing, to determine the type of EGFR mutation present.

“The approval of Gilotrif as a targeted therapy for these additional non-resistant EGFR mutations significantly alters the treatment strategy for this population,” according to Edward Kim, M.D., of the Levine Cancer Institute in the Carolinas HealthCare System.

Approximately 10% of NSCLC patients with EGFR mutations have rare or uncommon mutations, resulting in limited treatment options.

“This approval is more welcome news for our lung cancer community,” commented Laurie Fenton Ambrose, president and chief executive officer of the Lung Cancer Alliance. “These types of advances are helping expand access to treatment options for patients who might benefit from targeted therapies to fight their specific type of lung cancer.”