Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

FDA Grants Priority Review to BI’s Gilotrif for Uncommon EGFR Mutations in Advanced NSCLC

By Boehringer Ingelheim | October 13, 2017

Boehringer Ingelheim today announced that the supplemental New Drug Application (sNDA) for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.

Gilotrif is already approved in the U.S., EU (Giotrif) and many other markets for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, and squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

“The acceptance of the sNDA filing with Priority Review recognizes our company’s ongoing commitment to further study Gilotrif in areas of high unmet medical need for patients with few treatment options,” said Martina Flammer, M.D., Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. “If approved for this additional indication, Gilotrif would offer the broadest first-line treatment option for patients with EGFR mutation-positive NSCLC.”

The submission is based on a meta-analysis of three clinical trials from the LUX-Lung clinical trial program that examined the efficacy of Gilotrif in patients whose tumors have uncommon EGFR mutations. The efficacy outcomes evaluated in the study included: objective response, disease control, duration of response, progression-free survival and overall survival.

Uncommon mutations, which include L861Q, G719X or S7681, represent less than 10 percent of the EGFR mutations found in NSCLC patients and are associated with poor prognosis and survival.

Priority Review designation is granted to applications for drugs that the FDA has determined have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions compared to available therapies. Under Priority Review, FDA typically takes action within six months of receiving a supplemental application, rather than 10 months, which is the standard review timeframe.


Filed Under: Drug Discovery

 

Related Articles Read More >

EVEREST lead investigator on why Dupixent sets a new bar for treating coexisting CRSwNP and asthma
Sanders, King target DTC pharma ads but the industry worries more about threats to its $2B R&D model
Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE