Therakos Development Limited, a global pioneer in immunomodulatory therapy delivered at the bedside through extracorporeal photopheresis (ECP), announced that its THERAKOS™ CELLEX™ Photopheresis System has received certification under the EU MDR for an expanded indication. The system is now indicated in Europe for the treatment of immune-related adverse events (irAEs) associated with immune checkpoint inhibitor (ICI) therapy in adults who have had an inadequate response to corticosteroids. It is the first and only therapy approved for this use anywhere in the world.

ICI therapy has transformed cancer care by harnessing the immune system to deliver durable antitumor responses. However, this same immune activation can trigger potentially severe irAEs, compromising treatment continuity and patient outcomes. Corticosteroids remain the standard initial treatment for clinically significant irAEs, often requiring interruption or discontinuation of ICI therapy. For patients who do not respond adequately, additional immunosuppressive treatments may be necessary, potentially further compromising antitumor immunity. These challenges underscore a critical unmet need for therapeutic approaches that effectively manage immune-related toxicities while preserving the benefits of cancer immunotherapy.

"The management of steroid-refractory irAEs remains a challenge since data on effectiveness of different drugs is scarce and immunosuppression can hinder antitumor response. The THERAKOS™ CELLEX™ Photopheresis System, which is now approved for this indication in Europe, represents a significant advancement in treatment of steroid-refractory irAEs," said Prof. Dr. Lucie Heinzerling, MPH, Professor of Dermatology and Venereology, LMU University Hospital, Ludwig Maximilian University.

"At Therakos, we are committed to addressing the needs of patients who are impacted by immune-related complications of ICI therapy," said Sandra Thompson, Co-Chief Executive Officer, Therakos. "As the first and only therapy approved to treat these complications, the THERAKOS™ CELLEX™ Photopheresis System gives European medical oncology teams an important new option for treating their patients."

ECP takes a different approach than traditional options. Rather than broadly suppressing the immune system, it is designed to help re-establish immune balance using the patient's own cells. The goal is to address the toxicity without broad immunosuppression. It is well established that immunosuppression can compromise the cancer therapy itself.

"Immune-related toxicity has long been treated as a systemic problem, but it's better understood as a tissue-specific one. ECP resolves inflammation at the site where it occurs, through the body's own anti-inflammatory signaling, rather than suppressing the immune system broadly. As immunotherapy reaches more patients and more combinations, managing its toxicity without compromising its benefit will define how far the field can go. This expanded indication in Europe puts a therapy that does exactly that in clinicians' hands," said Prof. Dr. Robert Zeiser, Professor of Medicine and Director of the Division of Tumor Immunology at the Department of Hematology, Oncology, and Stem-Cell Transplantation at the Medical Center University of Freiburg.

Clinicians can access the THERAKOS™ CELLEX™ Photopheresis System 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 as a result of this MDR approval.