Therakos Receives EU Approval for Photopheresis System
The THERAKOS CELLEX system is now certified for immune-related adverse events in European adult patients.
Updated on Oct. 21, 2026 in Cancer
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Therakos Development Limited announced that its THERAKOS CELLEX Photopheresis System has received EU MDR certification for an expanded clinical indication. The system is the first therapy approved to treat immune-related adverse events in adults who have not responded adequately to corticosteroids.
Why it matters
Managing immune-related adverse events often forces clinicians to discontinue immune checkpoint inhibitor therapy in cancer patients. This system offers a way to restore immune balance using a patient's own cells instead of relying on broad systemic suppression.
The system is now available across a network of 190 treatment centers in Europe. It is indicated for adult patients who show insufficient response to corticosteroids after immune checkpoint inhibitor therapy.
The players
Therakos Development Limited
This company specializes in extracorporeal photopheresis technology and is headquartered in Dublin.
The details
The treatment process involves collecting a small volume of a patient's white blood cells, treating them with a photoactive agent and ultraviolet A light, and returning them to the body. This approach aims to re-establish immune balance without the need for systemic immunosuppressants that often interfere with cancer treatment.
Timeline
October 22, 2026: Therakos officially announced the new EU MDR certification.
The Big Picture
This approval aligns with the standards set by the European Union Medical Device Regulation (EU MDR) to ensure rigorous clinical oversight of medical devices. It represents a shift toward more precise management of side effects associated with modern oncology treatments.
Patients experiencing complications from checkpoint inhibitor therapy may now have a new option that avoids the need for broad immunosuppression. Clinicians can coordinate this treatment through the existing European network of 190 certified centers.
The takeaway
This development provides a new pathway for managing severe immune responses without interrupting critical oncology treatments. Patients should consult their care teams to determine if this procedure is appropriate based on their specific health history and response to steroids.
Further reading
For more information on the latest clinical advancements, see our Cancer section.
More information
View the Therakos official product information portal to learn more about the system's clinical indications.
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