Public Release: 

Lung cancer patients gain access to new treatment for 4th time in 2 months

IASLC Heralds FDA's speed in approving new lung cancer therapies

International Association for the Study of Lung Cancer

DENVER - The International Association for the Study of Lung Cancer (IASLC) is pleased to hear of another approval by the U.S. Food and Drug Administration (FDA) that helps in the fight against lung cancer -- the fourth in two months. The FDA approved necitumumab (PortrazzaTM) in combination with standard chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for their advanced disease.

Necitumumab binds to the epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors, and blocks EGFR from binding its ligands, thus preventing tumor growth. Necitumumab is the first monoclonal antibody type of EGFR inhibitor to be approved in lung cancer, whereas there are a number of tyrosine kinase type of EGFR inhibitors (TKI) already FDA approved and used in clinical practice. These TKIs include gefitinib, erlotinib, afatinib, and osimertinib.

"This marks the fourth approval by the FDA in less than two months for a therapeutic designed to treat lung cancer. This is remarkable. It demonstrates the amount of progress being made in the field and the new hope that exists for lung cancer patients, especially those with squamous histology," said Fred R. Hirsch, MD, PhD, Professor of Medicine and Pathology at the University of Colorado Cancer Center and School of Medicine and CEO of the IASLC.

In early October the FDA granted approval for two new immunotherapy treatments, nivolumab and pembrolizumab, and just a week ago osimertinib , a 3rd-generation EGFR TKI, was approved under the accelerated approval process. These new therapies come at a key time and offer many more options for patients and physicians alike. Lung cancer causes more than 1.6 million deaths each year around the world. That is more than breast, colon and prostate cancer combined. It is the leading cause of global cancer deaths.

"Scientific progress continues to move rapidly as we all work to turn the tide against lung cancer. It is an exciting time for lung cancer researchers and a very hopeful time for lung cancer patients," Dr. Hirsch said.

This approval of necitumumab came about because of information gathered through the phase 3 SQUIRE (SQUamous NSCLC treatment with the Inhibitor of EGF Receptor) clinical trial, the largest trial reported for patients with advanced squamous NSCLC. Dr. Hirsch played a key role in the SQUIRE trial.

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For more information about necitumumab, visit the FDA's website: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474131.htm.

About the IASLC

The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer. Founded in 1974, the association's membership includes more than 4,000 lung cancer specialists in over 90 countries. Visit http://www.iaslc.org for more information.

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