CEL-SCI Corporation announced in May 2024 that the U.S. Food and Drug Administration (FDA) indicated it may proceed with a confirmatory registration study for its lead investigational therapy, Multikine. This decision marks a significant step forward in the development pathway for the cancer immunotherapy.
The planned study is designed as a randomized controlled trial and will enroll 212 patients. It will specifically focus on a target population of newly diagnosed advanced primary head and neck cancer patients who demonstrated the greatest survival benefit in the prior Phase 3 trial.
This regulatory allowance is crucial for CEL-SCI as it provides a defined pathway towards potential marketing approval for Multikine, addressing an unmet medical need in a specific patient population.
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