DARZALEX® Becomes First Oncology Injectable Approved for Self-Administration in Europe
Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved a Type II variation to the labelling of DARZALEX® (daratumumab) subcutaneous formulation, enabling eligible patients or caregivers to administer the treatment from the fifth dose onwards following appropriate training and clinical assessment.
The decision marks the first oncology injectable approved for self-administration by patients or caregivers in Europe.
The approval applies to all ten therapeutic indications for daratumumab subcutaneous treatment across multiple myeloma, smouldering multiple myeloma and light chain (AL) amyloidosis.
Multiple myeloma remains an incurable blood cancer characterised by repeated relapse and the need for ongoing therapy. Approximately 380 people are diagnosed with the condition annually in Ireland, while more than 2,000 people are currently living with the disease nationwide.
Professor Paul Browne, Chairperson of Multiple Myeloma Ireland and Professor of Haematology at Trinity College Dublin, said the development could significantly improve flexibility and independence for patients.
“Living with multiple myeloma often means regular hospital visits, which can be a burden for patients trying to maintain their daily lives,” he said.
“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.”
Dr Bríd Seoighe, Medical Director at Johnson & Johnson Innovative Medicine Ireland, said the update reflected evolving patient and clinician needs.
“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.”
Johnson & Johnson noted that daratumumab has become a foundational therapy in multiple myeloma treatment, with more than 748,000 patients treated globally since launch.
DARZALEX® is currently the only CD38-directed antibody approved for subcutaneous administration in multiple myeloma treatment. The therapy works by binding to CD38 proteins found on myeloma cells, helping inhibit tumour cell growth and promote cancer cell death.
According to the company, data from ten Phase 3 clinical trials demonstrated significant improvements in progression-free survival and overall survival across newly diagnosed and relapsed multiple myeloma patient populations.
References:
- Johnson & Johnson. Press Release: DARZALEX® becomes the first oncology injectable approved for administration by patients or caregivers. 7 May 2026.
- National Cancer Registry Ireland. Multiple Myeloma Factsheet.
- European Medicines Agency (EMA). Committee for Medicinal Products for Human Use (CHMP).