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.
The Unmet Need in Head and Neck Cancer
Head and neck cancers (HNCs) account for 5% of all cancer cases in Saudi Arabia, which is around 650–700 new cases every year. Mostly affecting men attributed to tobacco use, including cigarettes, shisha, and smokeless tobacco like shamma. In the southern provinces like Jazan, shamma use is linked to high oral cancer rates, including among women.
Head and neck cancers are often diagnosed at advanced stages, with 80% or more of patients having lymph node involvement at diagnosis. The most common subtypes in the Kingdom are oral cavity and nasopharyngeal carcinomas. Despite advances in surgery and radiation, 5-year survival rates have plateaued at 50%, so there is a big need for more effective first-line treatment options.
The Science Behind Multikine
Multikine (Leukocyte Interleukin, Injection) is a unique immunotherapeutic biologic composed of a carefully calibrated mix of natural cytokines derived from activated human white blood cells. Unlike checkpoint inhibitors used in later-stage cancers, Multikine is designed to be administered before surgery, while the patient’s immune system is still intact and the tumor is present as a target.
In CEL-SCI’s global Phase III trial, the largest ever conducted in head and neck cancer, Multikine demonstrated a statistically significant improvement in five-year survival rates for a defined patient subgroup: those treated with surgery followed by radiation but not chemotherapy. Among these patients, five-year survival improved from 48.6% to 62.7%, effectively cutting the risk of death nearly in half.
Multikine also showed strong safety results, with no late toxicities reported and notable improvements in patient-reported quality of life. Some patients experienced complete tumor regression before surgery, supporting the idea that Multikine may sensitize tumors to subsequent standard treatments.
Alignment with Saudi Vision 2030
The approval of Multikine fits perfectly into Saudi Vision 2030, the national framework for economic diversification and innovation that includes transforming the healthcare and biotech sectors. Central to this transformation is the localization of pharmaceutical manufacturing, attracting clinical research, and becoming a regional hub for medical innovation.
The SFDA’s Breakthrough Medicine Designation, modeled after similar programs in the U.S. and EU, is a direct byproduct of this strategy. It aims to expedite the approval of therapies that show significant clinical promise in addressing unmet medical needs. By targeting a cancer type with limited first-line advancements, Multikine qualifies as a prime candidate for such accelerated evaluation.
Saudi Arabia has also shown leadership in adopting advanced oncology treatments. The country recently became the first in the region to manufacture CAR-T cell therapies domestically, reducing costs and access times for blood cancer patients. The addition of Multikine would continue this trend of delivering next-generation therapeutics within the Kingdom.
Oncology Infrastructure Ready for Innovation
Saudi Arabia’s oncology infrastructure has matured significantly over the last decade. Institutions like King Faisal Specialist Hospital & Research Centre (KFSHRC), King Fahad Medical City (KFMC), and Princess Noorah Oncology Center are now equipped with the latest technologies, including proton therapy and precision diagnostics.
These institutions routinely adopt new cancer treatments and maintain specialized head and neck cancer teams composed of ENT surgeons, radiation oncologists, medical oncologists, and rehabilitation professionals. The availability of multidisciplinary tumor boards and growing use of tele-oncology services further support the clinical integration of innovative therapies like Multikine.
The Ministry of Health’s e-Platform for oncology consultations ensures that even patients in remote regions can access national expertise, which is an essential element as the country decentralizes specialist care under the Vision 2030 framework.
Regional and Global Impact
If Saudi Arabia approves Multikine in 2025, it will not only be a therapeutic breakthrough for patients but also a model for fast-tracking drug development in the MENA region. CEL-SCI has already announced plans to partner with a local manufacturer in the Kingdom to supply Multikine across the Middle East and North Africa.
The implications go beyond geography. An early Saudi approval will strengthen CEL-SCI’s case for conditional approvals in other jurisdictions, including Canada and the EU, where the company has filed parallel regulatory submissions.
What’s Ahead
Multikine’s journey of over a decade of clinical development is the potential of immunotherapy to improve survival in areas where there are few options. Saudi Arabia’s regulatory and clinical leadership may now be the launchpad for this innovation.
For patients newly diagnosed with head and neck cancer in the Kingdom, this means more than hope. It soon means potential access.
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