The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) met on September 27, 2024, to evaluate the use of checkpoint inhibitors in various cancers. The panel voted 10-2 and 11-1 against the risk-benefit profile for PD-L1 inhibitors in two separate votes.
Most ODAC members expressed concerns regarding the lack of benefit demonstrated for patients with low PD-L1 expression. Some members also pointed to evidence that the use of immune checkpoint inhibitors may add unnecessary toxicities and financial burdens for these patients.
CEL-SCI Corporation stated that this ODAC decision substantiates Multikine's potential to address a major treatment gap for low and negative PD-L1 patients. Multikine is targeted to and has shown survival benefit in this specific population, which represents approximately 70% of head and neck cancer patients.
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