Keytruda (pembrolizumab) filed with FDA for marketing approval in NSCLC-Merck Inc
Merck has submitted a supplemental Biologics License Application to the FDA for Keytruda (pembrolizumab), the company�s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). This initial filing seeks approval in the treatment of patients with advanced NSCLC whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present.
The submission is based on data from KEYNOTE-001 in patients with greater than or equal to 50 percent of tumor cells positive for PD-L1 expression. In the total study population, Overall Response Rate was 19.4 percent, which was consistent with data previously presented from this study. Data from KEYNOTE-001 has also been published in the New England Journal of Medicine: "Pembrolizumab for the Treatment of Non�Small-Cell Lung Cancer" Edward B. Garon et al. NEJM April 19, 2015DOI: 10.1056/NEJMoa1501824.Comment: A Premarket Approval Application was submitted by Dako North America, Inc for an immunohistochemistry companion diagnostic test that detects PD-L1 expression, PD-L1 IHC 22C3 PharmDx.
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