The U.S. Food and Drug Administration (FDA) has granted accelerated approval for pembrolizumab (Keytruda) for the treatment of patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express the programmed death-ligand 1 (PD-L1) protein.1

The immunotherapy is approved for use with the PD-L1 IHC 22C3 pharmDx companion diagnostic test, the first test designed to detect PD-L1 expression in patients with NSCLC tumors.

“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”

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The safety and effectiveness of pembrolizumab for NSCLC was evaluated in 550 participants with NSCLC enrolled in a multicenter, open-label, multi-part study.

Results showed that tumors shrank in 41% of the 61 patients with advanced NSCLC that progressed after platinum-based chemotherapy or, if appropriate, targeted therapy for ALK or EGFR mutations.

In regard to safety, the most common adverse events associated with pembrolizumab in these patients were fatigue, decreased appetite, dyspnea, and cough. Clinicians should be aware that pembrolizumab can also cause severe immune-mediated side effects occurring in the lungs, colon, and hormone-producing glands.

Pembrolizumab for advanced NSCLC should be administered at a dose of 2 mg/kg intravenously over 30 minutes. Clinicians should monitor for changes in hepatic, renal, and thyroid function, hyperglycemia, and infusion-related reactions.

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Pembrolizumab is also indicated for the treatment of patients with unresectable or metastatic melanoma.

The American Cancer Society estimates that about 221,200 new cases of lung cancer will be diagnosed in the United States in 2015 and about 158,040 deaths will occur from the disease. NSCLC is the most common type of lung cancer.


  1. FDA approves Keytruda for advanced non-small cell lung cancer [news release]. Silver Spring, MD: FDA News Release; October 2, 2015. Accessed October 2, 2015.