The Food and Drug Administration has expanded approval of the PD-1 inhibitor Opdivo® (nivolumab) to include treatment of patients who have metastatic squamous non–small cell lung cancer (NSCLC) that progresses following treatment with platinum-based chemotherapy.

Nivolumab belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer.  PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Nivolumab works by blocking PD-1. PD-1 inhibitors are being investigated in more than 30 different cancers, and early studies in melanoma are promising.

Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. Although progress has been made in recent years, the majority of patients with advanced stage lung cancer still die from their disease. New treatments are sorely needed.

Nivolumab treatment for squamous NSCLC was reviewed under the FDA’s priority review program, and is being approved more than 3 months ahead of schedule.  Nivolumab’s effectiveness was established in a trial of 272 patients with metastatic squamous NSCLC and demonstrated a median overall survival improvement of 3.2 months compared to treatment with docetaxel.

Reference:  Kawaguchi T, Ando M, Asami K, et al. Randomized Phase III Trial of Erlotinib Versus Docetaxel As Second- or Third-Line Therapy in Patients With Advanced Non–Small-Cell Lung Cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA). J Clin Oncol 2014;32:1902-1908.

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