Boehringer Ingelheim announced the approval of a new indication for afatinib (Gilotrif), as the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (NDA) 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.

With the news, afatinib now offers the broadest first-line indication of any tyrosine kinase inhibitor (TKI) for EGFR mutation-positive (EGFR+) NSCLC.

NSCLC itself is not an uncommon form of cancer, but the subset of patients who have EGFR+ NSLCL are considered rare. The majority of EGFR mutation-positive NSCLC cases are attributed to the most common EGFR mutations: exon 19 deletions and L858R. An estimated 10% of NSCLC patients with EGFR mutations have rare or uncommon mutations.

Afatinib was initially approved in the United States in 2013 for patients with squamous cell carcinoma of the lung whose disease progressed after treatment with platinum-based chemotherapy. Today’s approval is based on results from 3 different studies from the LUX-Lung clinical trial program (Phase II LUX-Lung 2 study and Phase III studies LUX-Lung 3 and LUX-Lung 6) that examined the drug in 32 NSCLC patients whose tumors had EGFR mutations, including L861Q, G719X or S768I.

Results proved afatinib's activity in these mutations based on objective response rate, duration of response, disease control, progression-free survival and overall survival.

“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, M.D., senior vice president of Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. 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.”

The FDA granted Priority Review status to afatinib in evaluating this application. To acquire the prescription medicine, patients must undergo genetic testing – or biomarker testing – to determine which type of EGFR mutation is present.

“Compared with other EGFR mutations, L861Q, G719X or S768I substitution mutations are associated with a poorer prognosis and limited treatment options,” said Edward Kim, M.D., 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.”