U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025
“To our knowledge, Multikine is the only neoadjuvant immunotherapy that has shown overall survival benefit in the low and negative PD-L1 head and neck cancer population. This underscores the critical importance of having reached an agreement with the FDA on the method for identifying and selecting patients with low PD-L1 tumor expression for our upcoming confirmatory Registration study,” stated CEL-SCI CEO Geert Kersten.
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