Therakos Expands Photopheresis System for ICI Therapy Complications

DUBLIN, Oct. 21, 2026 /CourierPR/ -- Therakos Development Limited, a global leader in immunomodulatory therapy, has expanded the use of its THERAKOS™ CELLEX™ Photopheresis System to treat immune-related adverse events (irAEs) associated with immune checkpoint inhibitor (ICI) therapy. The system, now approved under the EU Medical Device Regulation (MDR), is the first and only therapy globally indicated for this specific use in adults who have not responded adequately to corticosteroids.

This approval comes as a significant advancement in managing irAEs, which can occur as a result of ICI therapy. ICI therapy, while transforming cancer care with durable antitumor responses, can also trigger severe irAEs, often requiring interruption or discontinuation of treatment. Corticosteroids, the standard initial treatment, may not be sufficient for all patients, necessitating additional immunosuppressive therapies that can further compromise antitumor immunity.

Therakos, committed to addressing the needs of patients impacted by immune-related complications of ICI therapy, now offers European medical oncology teams an important new option. The THERAKOS™ CELLEX™ Photopheresis System works by re-establishing immune balance using the patient's own cells, rather than broadly suppressing the immune system. This approach aims to address toxicity without compromising the benefits of cancer immunotherapy.

The THERAKOS™ CELLEX™ Photopheresis System is now available for irAEs associated with ICI therapy in adults who have had an inadequate response to corticosteroids, through an existing network of over 190 centres in Europe. The system is also approved for use in EU MDR jurisdictions in patients older than 3 years of age for managing acute and chronic graft versus host disease (GvHD).

While the system offers a promising treatment option, it is important to note that it is not without risks. The THERAKOS™ CELLEX™ Photopheresis System is contraindicated in patients with a specific history of a light-sensitive disease, those who cannot tolerate extracorporeal volume loss, or those with white blood cell counts greater than 25,000 / mm³. Additionally, patients who have coagulation disorders or have previously undergone a splenectomy are also contraindicated.

The treatment involves collecting a small volume of the patient's white blood cells, treating them with a photoactive agent and ultraviolet A light, and then returning them to the patient. The process is designed to address inflammation at the site of occurrence, rather than broadly suppressing the immune system.

According to the press release, transient pyretic reactions, ranging from 37.7 to 38.9°C (100 to 102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. Patients are advised to wear UVA-absorbing, wrap-around sunglasses for twenty-four hours after methoxsalen treatment and to avoid direct or indirect sunlight exposure.

Therakos Development Limited continues to advance the science of immunomodulation, aiming to improve outcomes for patients living with complex immune-mediated diseases. The company's mission is to restore and protect human immunity, and the approval of the THERAKOS™ CELLEX™ Photopheresis System for treating irAEs associated with ICI therapy is a significant step towards achieving this goal.