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FDA Lowers Pembrolizumab PD-L1 Cutoff in NSCLC, Expands Approval to Stage III

Gina Columbus @ginacolumbusonc
Published: Thursday, Apr 11, 2019

The FDA has expanded the approval for pembrolizumab (Keytruda) monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer (NSCLC), who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression (tumor proportion score [TPS]) level of ≥1% and do not harbor EGFR or ALK aberrations.1



  1. FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%). FDA. Published April 11, 2019. Accessed April 11, 2019.
  2. Lopes G, Wu YL, Kudaba I, et al. Pembrolizumab (pembro) versus platinum-based chemotherapy (chemo) as first-line therapy for advanced/metastatic NSCLC with a PD-L1 tumor proportion score (TPS) ≥ 1%: Open-label, phase 3 KEYNOTE-042 study. Presented at: 2018 ASCO Annual Meeting; June 1-5; Chicago. Abstract LBA4.

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