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FDA Approves Necitumumab for Squamous NSCLC

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has approved necitumumab (Portrazza) in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC), based findings from the phase III SQUIRE trial.

In the 1093-patient study, the addition of the fully human IgG1 anti-EGFR monoclonal antibody necitumumab to gemcitabine and cisplatin improved overall survival (OS) by 1.6 months, which was equivalent to a 16% reduction in the risk of death. Progression-free survival (PFS) was improved by 15% with the triplet therapy.

The FDA approval follows an informal recommendation from the Oncologic Drugs Advisory Committee in July 2015. Following a discussion on the clinical trial results from the SQUIRE trial, the consensus of the panel was that the benefits of necitumumab were modest, yet clinically significant. Click here to read the full article at

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