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FDA Grants Frontline Pembrolizumab Priority Review for Lower PD-L1 Cutoff in NSCLC

Kristie L. Kahl
Published: Wednesday, Sep 12, 2018

Dr. Roy Baynes

Roy Baynes, MD, PhD
The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for single-agent pembrolizumab (Keytruda) for the frontline treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer (NSCLC) with a PD-L1 expression (tumor proportion score [TPS]) level of ≥1% and no EGFR or ALK genomic tumor aberrations.

Pembrolizumab has FDA-approved indications in melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, primary mediastinal large B-cell lymphoma, and microsatellite instability–high solid tumors.
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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