Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) of its Gilotrif (afatinib) as first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations.

The agency previously approved Gilotrif for the first-line treatment of NSCLC patients whose tumours have exon 21 L858R mutations. The new indication covers L861Q, G719X and S768I EGFR mutations.

The sNDA included data from the pooled analysis of Phase II LUX-Lung 2 and Phase III LUX-Lung 3 and LUX-Lung 6 studies under the LUX-Lung clinical trial programme in patients with EGFR mutation-positive NSCLC.

Based on objective response rate, disease control, duration of response, overall survival and progression-free survival, the analysis revealed that Gilotrif was active in the L861Q, G719X and S768I mutations.

“The agency previously approved Gilotrif for the first-line treatment of NSCLC patients whose tumours have exon 21 L858R mutations.”

Boehringer Ingelheim Pharmaceuticals Medicine and Regulatory Affairs senior vice-president Sabine Luik said: “With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations.

“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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The FDA has recommended the use of biomarker testing before treatment with Gilotrif to identify the type of EGFR mutation in a patient.

Gilotrif is additionally indicated in the US for the treatment of lung squamous cell carcinoma in patients who have progressed after platinum-based chemotherapy.