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FDA Delays Decision on Frontline Pembrolizumab sBLA in NSCLC

Jason M. Broderick and Kristie L. Kahl
Published: Friday, Dec 21, 2018

lung cancer
The FDA has extended the review period for 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.

In addition, these patients experienced fewer severe adverse events (AEs; 17.8% vs. 41%). Treatment-related AEs occurred more often in those who received chemotherapy (89.9% vs 62.7%) compared with pembrolizumab, which led to discontinuation in 9.4% and 9% of patients, respectively.
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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