FDA to Expand the Use of Gilotrif

Boehringer Ingelheim ’s therapeutic is approved to treat more types of lung cancer. 

The FDA has approved a supplemental New Drug Application (sNDA) and granted Priority Review status for Boehringer Ingelheim’s Gilotrif® (afatinib). The drug has been accepted for patients who have metastatic non-small cell lung cancer (NSCLC) that also have tumors with non-resistant epidermal growth factor receptor (EGFR) mutations. These EGFR mutations had to have been determined via FDA backed testing. Gilotrif®’s new label includes data on a greater number of EGFR mutations namely, L861Q, G719X and S768I.

Prior to these added indications, Gilotrif had been granted US approval for the first-line treatment of patients with NSCLC, with tumors that express EGFR exon 19 deletions or exon 21 L858R mutations. Gilotrif is also approved for the treatment of squamous cell carcinoma in the lung, in patients whose cancer has progressed in spite of platinum-based chemotherapy treatment.

Sabine Luik, M.D., Senior Vice President of Medicine & Regulatory Affairs for Boehringer Ingelheim Pharmaceuticals, Inc., commented on the sped up approval courtesy of the FDA. "With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations," she commented.

The supplemental new drug application approval was based on the outcome of three clinical trials. The LUX-Lung clinical trial program (Phase II LUX-Lung 2 study and Phase III studies LUX-Lung 3 and LUX-Lung 6) treated NSCLC patients, whose tumors have EGFR mutations, including L861Q, G719X or S768I, with Gilotrif. Data from this trial revealed that Gilotrif was active in these EGFR mutations. This analysis was based on the patient response rate, the length of response and overall disease control, as well as progression-free survival and survival, in general. 

Edward Kim, M.D., Levine Cancer Institute, Carolinas HealthCare System commented on the difficulty in treating patients that express these specific mutations. "Compared with other EGFR mutations, L861Q, G719X or S768I substitution mutations are associated with a poorer prognosis and limited treatment options," he stated. Kim noted that in spite of this, Gilotrif holds promise. "The approval of Gilotrif as a targeted therapy for these additional non-resistant EGFR mutations significantly alters the treatment strategy for this population," he said of the therapy.

Laurie Fenton Ambrose, President and CEO of Lung Cancer Alliance, echoed this optimism. "This approval is more welcome news for our lung cancer community," she said. "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,”. she continued.

The most regularly diagnosed form of lung cancer is non-small cell lung cancer (NSCLC). EGFR mutation-positive NSCLC is generally linked with EGFR mutations (exon 19 deletions or L858R), which are the two most common forms. Ten percent of NSCLC patients that express EGFR mutations also have rare or uncommon mutations, which significantly lessen their options for treatment. Gilotrif is available as an oral, once daily tablet.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.