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FDA approves Keytruda for advanced NSCLC
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The FDA today granted accelerated approval to pembrolizumab for treatment of previously treated patients with metastatic non–small cell lung cancer whose tumors express PD-L1.
Pembrolizumab (Keytruda, Merck) is approved in conjunction with the PD-L1 IHC 22C3 pharmDx test, a companion diagnostic created to detect PD-L1 expression in NSCLC tumors.
Richard Pazdur
“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”
Pembrolizumab — previously approved for certain patients with advanced melanoma — blocks the PD-1/PD-L1 pathway, allowing the body’s immune system to fight cancer cells.
A subgroup analysis (n = 61) of a multicenter, open-label study showed pembrolizumab induced response in 41% of patients with PD-L1–positive NSCLC tumors whose tumors progressed after platinum-based chemotherapy or, if appropriate, targeted therapy for ALK or EGFR mutations. These responses lasted 2.1 months to 9.1 months.
A safety analysis that included 550 patients with advanced NSCLC showed the most common side effects associated with pembrolizumab included fatigue, decreased appetite, shortness of breath or impaired breathing, and cough. Researchers also reported incidence of some severe immune-mediated side effects involving the lungs, colon and hormone-producing glands.