DUBLIN, IRELAND, 7th May 2026 – Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted approval for a Type II variation to the labelling for DARZALEX® (daratumumab) subcutaneous (SC) formulation. The label update enables patients living with multiple myeloma or their caregivers to administer daratumumab from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.[1] This landmark decision makes daratumumab the first oncology injectable approved for self-administration in Europe.[1]
Multiple myeloma remains an incurable blood cancer, with nearly all patients relapsing and requiring subsequent therapy.[2],[3]. Approximately 380 people are diagnosed with multiple myeloma each year in Ireland and over 2,000 people are currently living with this type of cancer.[4] It’s more common in people over 60, in those who have a family member with the condition, or in people who have been exposed to certain chemicals or radiation.[5] It tends to affect men slightly more often than women.[4]
Offering greater flexibility in care
With this label update, patients and their healthcare professionals can work together to decide the most suitable choice of administration.[1] It applies to all ten therapeutic indications of daratumumab SC for multiple myeloma, smouldering multiple myeloma and light chain (AL) amyloidosis.
“Living with multiple myeloma often means regular hospital visits, which can be a burden for patients trying to maintain their daily lives,” commented Professor Paul Browne, Chairperson of Multiple Myeloma Ireland and Professor of Haematology at Trinity College Dublin. “This development will empower patients by giving them more independence and flexibility in how or where they receive their care. It also offers our healthcare system a way to alleviate some capacity pressures, reducing the number of hospital visits.”
Building on a decade of innovation with daratumumab
“For over two decades, Johnson & Johnson has remained committed to improving outcomes for people living with multiple myeloma,” said Dr Bríd Seoighe, Medical Director at Johnson & Johnson Innovative Medicine Ireland. “While treatment has advanced, significant challenges persist. Inspired by real-world experience and feedback from patients and physicians, we recognised a clear and growing need to evolve how treatment is delivered. This is about much more than convenience. It is about redefining how treatment fits into patients’ lives, while we ensure care is tailored by clinicians and patients to their individual needs.”
About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.
In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide.[6] Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.[7] Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.[7]
CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.[7] Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.7 Daratumumab may also have an effect on normal cells.[7] Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.[8],[9],[10],[11],[12],[13],[14],[15],[16],[17].
For further information on daratumumab, please see the Summary of Product Characteristics at: https://www.medicines.ie/medicines/darzalex-1-800-mg-solution-for-injection-34971/spc
