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Therakos Receives Important EU MDR Approval

DUBLIN, Oct. 21, 2026 — Therakos Development Limited, a leader in immunomodulatory therapy, has announced that its innovative THERAKOS™ CELLEX™ Photopheresis System has officially received certification under the EU's Medical Device Regulation (MDR) for a critical new indication. This approval allows for the treatment of immune-related adverse events (irAEs) that occur in patients undergoing immune checkpoint inhibitor (ICI) therapy, specifically when they do not respond adequately to corticosteroid treatment. This makes it the first therapy of its kind approved globally for this purpose.

Background on Immune Checkpoint Inhibitor Therapy

ICI therapy has revolutionized cancer treatment by leveraging the body’s immune system to produce lasting anti-tumor effects. However, this potent immune activation can also lead to significant adverse effects, known as irAEs, which can hinder treatment progress and negatively impact patient outcomes. While corticosteroids are the standard initial approach for managing these adverse effects, they often necessitate the interruption of ICI therapy, posing a considerable challenge for clinicians.

The Need for Innovative Solutions

The reality is that many patients continue to experience persistent adverse events even after corticosteroid intervention, leading to a critical gap in effective treatment options. Sandra Thompson, Co-CEO of Therakos, expressed the need for solutions that specifically address these complications of ICI therapy, stating, “As the first and only therapy approved to treat these complications, the THERAKOS™ CELLEX™ Photopheresis System provides medical teams in Europe with a vital addition to their treatment arsenal.”

Advancements in Treatment

The THERAKOS™ CELLEX™ Photopheresis System distinguishes itself as it operates differently from conventional therapies. Rather than inducing broad immunosuppression, which can complicate cancer treatment, ECP is designed to utilize the patient's own immune cells to restore balance to their immune response. This targeted technology allows for localized management of inflammation at the site of irAEs, drawing on the body’s own mechanisms for anti-inflammatory signaling.

Prof. Dr. Robert Zeiser, an expert in tumor immunology, emphasizes the importance of this localized approach, stating, “Immune-related toxicity has historically been viewed as a systemic issue, yet it is more accurately characterized as a tissue-specific problem. ECP addresses inflammation precisely where it occurs, without compromising the overall immune response.”

Accessibility and Implementation

With this new EU MDR approval, the THERAKOS™ CELLEX™ Photopheresis System is available for clinical use across existing networks of over 190 centers in Europe. This robust infrastructure will facilitate timely access to the therapy for patients experiencing steroid-refractory irAEs. Prof. Dr. Lucie Heinzerling from LMU University Hospital noted, “The availability of THERAKOS™ CELLEX™ represents a significant step forward in our ability to manage the challenges posed by steroid-refractory irAEs in cancer therapy.”

Conclusion

The certification by the EU MDR not only affirms Therakos' commitment to advancing cancer treatment protocols but also presents an essential tool for oncologists aiming to navigate the complexities of immunotherapy-related adverse effects. As therapies continue to evolve, the incorporation of innovative solutions like the THERAKOS™ CELLEX™ system may redefine patient care in oncology.

For additional information on Therakos and its pioneering therapies, visit Therakos' official website.