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Therakos Receives MDR Approval in Europe for Immune-Related Adverse Events

On October 21, 2026, Therakos Development Limited proudly announced that its THERAKOS™ CELLEX™ system secured certification under the Medical Device Regulation (MDR) in the European Union. This approval expands the device's indications for treating immune-related adverse events (irAEs) linked to immune checkpoint inhibitor (ICI) therapy in adults who have not adequately responded to corticosteroids. This positions it as the first and only therapy worldwide for such usage.

The Transformative Role of ICI Therapy

ICI therapy has revolutionized cancer treatment by leveraging the immune system to foster durable antitumor responses. However, this immune activation can inadvertently trigger potentially severe irAEs, which may compromise treatment continuity and negatively impact patient outcomes. Corticosteroids have long been the standard initial treatment for significant clinical irAEs, often necessitating the interruption or cessation of ICI therapy. In cases of inadequate response, additional immunosuppressive treatments are frequently required, which further threaten the antitumor immunity vital to cancer treatment.

Addressing Unmet Needs in Patient Care

"Managing corticosteroid-refractory irAEs continues to pose challenges, as data on various drug efficacy is limited and immunosuppression can hinder antitumor responses," stated Prof. Dr. Lucie Heinzerling, a Dermatology and Venereology expert at the LMU University Hospital. She emphasized that Therakos' CELLEX system, already approved for this indication in Europe, signifies a substantial advancement in addressing corticosteroid-refractory irAEs.

Sandra Thompson, co-CEO of Therakos, affirmed the company’s commitment to meet the needs of patients facing complications from ICI therapy. With the THERAKOS™ CELLEX™ system being the first and only therapy approved for such complications, it offers medical oncology teams in Europe an essential new treatment option.

Unique Immunomodulatory Approach of ECP

ECP represents a departure from traditional treatment methodologies. Instead of broadly immunosuppressing the body, it aims to restore immune balance utilizing the patient's own cells. This strategy specifically targets toxicity without resorting to extensive immunosuppression, which is known to compromise cancer therapy.

Prof. Dr. Robert Zeiser, a leading figure in Tumor Immunology, remarks, "Traditionally, immune-related toxicity has been perceived as a systemic issue; however, it is more accurately regarded as a tissue-specific phenomenon. ECP addresses inflammation where it originates, harnessing the body’s own anti-inflammatory signaling mechanisms rather than general immunosuppression. As immunotherapy extends to more patients and incorporates various therapeutic combinations, effective management of its toxicity without undermining its benefits will dictate the future scope of this field. This indication expansion in Europe equips physicians with a therapy that accomplishes precisely that."

Enhanced Access for Healthcare Providers

Thanks to this MDR approval, healthcare providers can utilize the THERAKOS™ CELLEX™ system for managing irAEs associated with ICI therapy in adult patients unresponsive to corticosteroids. This access is facilitated through an existing network of over 190 centers throughout Europe.

About Therakos

Therakos is a global leader in autologous immunomodulatory therapy delivered at the bedside through ECP. Backed by over four decades of clinical experience and evidence-based medicine, the Therakos ECP system was one of the first cell-based immunomodulatory therapies approved by the FDA. The company’s mission is to restore and protect human immunity, focusing on re-establishing immune balance by leveraging the patient’s own cells. Through ongoing investments in research, evidence generation, and innovation, Therakos drives the science of immunomodulation forward, enhancing outcomes for patients grappling with complex immune-mediated diseases. For more information, visit Therakos.

Understanding Extracorporeal Photopheresis (ECP)

ECP is an immunomodulatory therapy administered at the bedside. It involves extracting a small quantity of white blood cells from the patient, treating them with a photosensitizing agent and UVA light, then reinfusing them into the patient. Unlike traditional approaches that broadly suppress the immune system, ECP restores balance using the patient’s own cells.

Important Safety Information for the THERAKOS™ CELLEX™ System

The THERAKOS™ CELLEX™ system is indicated for patients over 18 years for photopheresis administration in cases such as:

• - Cutaneous T-cell lymphoma (CTCL)
• - Solid organ transplant rejection (heart, lung)
• - Treatment of immune-related adverse events (irAEs) related to ICI therapy in patients with inadequate response to corticosteroids.

Additionally, the system is approved for the treatment of acute and chronic graft-versus-host disease (aGvHD, cGvHD) in patients older than three years within MDR jurisdictions in the EU.

Contraindications

The system is contraindicated for:

• - Patients with specific histories of photosensitivity disorders.
• - Patients unable to tolerate extracorporeal volume loss or with a white blood cell count exceeding 25,000/mm³.
• - Patients with clotting disorders or previous splenectomy.

Warnings and Precautions

ECP treatments must be performed in settings equipped for emergency medical situations. Proper volume replacement fluids and/or volume expanders must be readily available throughout the procedure.

Adverse Events

Patients may experience hypotension during extracorporeal circulation procedures. Fever may also occur six to eight hours post reinfusion of photoactivated leukocytes. Other risks include mild infection and pain from venous access.

For a full list of warnings and precautions, consult the operator’s manual for the THERAKOS™ CELLEX™ system.