CEL-SCI Corporation has announced a significant development in the regulatory review process for its Multikine immunotherapy. The U.S. Food and Drug Administration (FDA) has paved a clear pathway for the potential accelerated approval of Multikine, following the FDA's recent priority review and approval of Merck's Keytruda for PD-L1 positive head and neck cancer patients. This approval was based on interim results from the Phase 3 KEYNOTE-689 trial. CEL-SCI's completed Phase 3 study demonstrated that Multikine significantly reduced the risk of death by 66% in patients with low to zero PD-L1 expression, extending 5-year overall survival to 73% compared to 45% in those receiving the standard of care. With about 70% of the patients in CEL-SCI's Phase 3 study expressing low to zero levels of PD-L1, Multikine has the potential to address a major unmet need in PD-L1 negative cancer patients. CEL-SCI has received the FDA's approval for a confirmatory registration study with 212 patients, marking a pivotal step towards regulatory approval.
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