Cel-Sci: Positive Meeting With FDA Over Multikine’s Approval for Head & Neck Cancer

CEL-SCI Corporation (NYSE American: CVM) today announced it has concluded a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the path forward for bringing Multikine* (Leukocyte Interleukin, Injection) immunotherapy to market for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN). During the recent meeting, the FDA acknowledged the longstanding need for improved treatments for head and neck cancer.

CEL-SCI believes the agency was collaborative and positive. Preliminary feedback from the FDA included that the selection criteria developed by CEL-SCI could be used to determine which patients should receive Multikine. Based on the feedback received at this recent meeting, CEL-SCI is preparing additional information about its development plan for the next meeting with the agency.

CEL-SCI is expecting scientific advice meetings with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in the fall of 2023. These are priority markets for CEL-SCI, as Europe has more than twice the number of head and neck cancer cases diagnosed each year as compared to the U.S.

https://www.biospace.com/article/releases/cel-sci-concludes-positive-meeting-with-u-s-fda-concerning-multikine-s-approval-for-head-and-amp-neck-cancer/