In a pivotal development in cancer care, Saudi Arabia may become the first country in the world to approve CEL-SCI Corporation's investigational immunotherapy, Multikine, for commercial use in treating head and neck cancer. The US-based biotech company has submitted an application to the Saudi Food and Drug Authority (SFDA) for Breakthrough Medicine Designation, a fast-track regulatory pathway that could make Multikine available to patients as early as this summer.
This move comes after favorable engagement between CEL-SCI and SFDA reviewers announced in April of this year, positioning Saudi Arabia at the forefront of global innovation in oncology. If approved, Multikine would represent a new era in immuno-oncology by becoming the first neoadjuvant (pre-surgical) immunotherapy available for advanced primary head and neck cancer.
