What is the story about?
What's Happening?
CEL-SCI Corporation has filed for a Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA) for its cancer immunotherapy, Multikine. This application was submitted by a leading Saudi pharmaceutical company, with which CEL-SCI has signed a Memorandum of Understanding for the commercialization of Multikine in Saudi Arabia. Multikine is designed to activate the immune system before surgery, radiation, and chemotherapy in patients with newly diagnosed head and neck cancer. The therapy has shown promising results in increasing the 5-year survival rate in clinical trials. The SFDA's response time for such applications is approximately 60 days, after which Multikine could become available for patient access and reimbursement in Saudi Arabia.
Why It's Important?
The filing for Breakthrough Medicine Designation in Saudi Arabia represents a significant step for CEL-SCI in expanding the global reach of its cancer immunotherapy. If approved, Multikine could offer a new treatment option for head and neck cancer patients, potentially improving survival rates and quality of life. The interest from Saudi investment funds and the potential for a joint venture to serve the Middle East and North Africa market highlights the growing demand for innovative cancer treatments in the region. This development aligns with Saudi Arabia's Vision 2030 and its National Biotechnology Strategy, emphasizing the importance of advancing healthcare solutions.
What's Next?
CEL-SCI anticipates a final partnership agreement with the Saudi pharmaceutical company during the third quarter of 2025. If the Breakthrough Medicine Designation is granted, Multikine will be immediately available for patient access and reimbursement in Saudi Arabia. CEL-SCI is also working with First Berlin and Saudi representatives to advance the commercialization program for Multikine, potentially expanding its availability to other regions in the Middle East and North Africa.
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