FDA expands use of pembrolizumab for NCSLC

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Approval was based on Keynote‑042, a randomized, multicenter, open-label, active-controlled trial conducted in 1,274 patients with stage III or IV NSCLC who had not received prior systemic treatment for metastatic NSCLC and whose tumors expressed PD-L1 (TPS ≥1 percent). PD-L1 expression was determined by an immunohistochemistry assay using the PD-L1 IHC 22C3 pharmDx Kit (Agilent Technologies).