FDA Expands Indication of Afatinib to Include EGFR-Mutated Lung Cancer

The FDA has approved a supplemental new drug application for afatinib (Gilotrif) as a first-line therapy for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, according to a press release from Boehringer Ingelheim.

The newly-approved label include data for 3 non-resistant EGFR mutations, L861Q, G719X, and S768I. Afatinib is not indicated to treat patients with resistant or abnormal EGRF genes, according to Boehringer.

“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, MD, senior vice president of Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “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 new approval was based on positive findings from an analysis of the phase two LUX-Lung 2 study and phase three LUX-Lung 3 and LUX-Lung 6 studies. These trials included patients with NSCLC whose tumors had EGFR mutations.

The study results indicated that afatinib improved objective response rate, duration of response, disease control, progression-free survival, and overall survival, according to the release.

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

Boehringer noted that in order to determine eligibility for treatment with afatinib, patients must undergo a biomarker test to indicate the type of EGFR mutation present, according to the release.

The FDA previously granted the application priority review status, according to the release.

Afatinib is also indicated as a first-line treatment for patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. Additionally, afatinib is approved to treat patients with squamous cell lung cancer who progressed after treatment with platinum-based chemotherapy.

“This approval is more welcome news for our lung cancer community,” said Laurie Fenton Ambrose, president and CEO of 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.”