FDA’s Oncologic Drugs Advisory Committee Decision on use of Multikine® in PD-L1 Negative Cancer Patients announced
“The FDA advisory committee’s findings and public statement on the risk-benefit of checkpoint inhibitors based on PD-L1 expression is potentially a turning point in cancer treatment, pointing to a major treatment gap in low and negative PD-L1 patients. While the approved blockbuster checkpoint inhibitors, including Keytruda which is expected to be the biggest selling drug in 2024, work well in high PD-L1 expressing patients, to our knowledge, Multikine is the only immunotherapy that is targeted to and has shown survival benefit in the low and negative PD-L1 population. CEL-SCI has already identified in our prior study low PD-L1 expression as a predictive biomarker, representing about 70% of head and neck cancer patients, which will be used as a selection criterion for our upcoming FDA confirmatory Registration Study of Multikine in the treatment of treatment-naïve resectable locally advanced head and neck cancer,” stated CEL-SCI CEO Geert Kersten.
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