The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved a Type II variation to the labelling for subcutaneous daratumumab (Darzalex) to allow patients with multiple myeloma or their caregivers to administer the agent from the fifth dose, if determined to be appropriate by their health care professional and following proper training.1
Daratumumab is now the first oncology injectable approved for self-administration in Europe.
“For many patients living with multiple myeloma, treatment can involve frequent hospital visits and the challenge of fitting care around everyday life,” Thomas Lund, MD, PhD, head of Hematological Section in the Department of Medicine at Vejle Hospital and the Department of Regional Health Research at the University of Southern Denmark, stated in a news release. “The possibility for self-administration of daratumumab subcutaneous represents meaningful progress for those who would prefer the opportunity for greater flexibility in how or where they receive their care. For the medical community, it reduces pressure on healthcare systems and provides healthcare professionals with more choice in how they tailor treatment to individual needs and preferences, while maintaining the well-established safety profile and efficacy of daratumumab.”
The label update covers all indications for subcutaneous daratumumab previously approved by the EMA. In Europe, daratumumab is approved:2
EMA Approves Subcutaneous Daratumumab for Patient/Caregiver Administration in Myeloma: Take-Home Points
- Daratumumab is the first oncology injectable approved in Europe for self-administration or administration by caregivers for patients with multiple myeloma.
- Self-administration or caregiver administration is allowed starting at the fifth dose, if determined to be appropriate by their health care professional and following proper training.
- The updated label for self-administration covers all 10 previously approved indications for subcutaneous daratumumab Europe.
- in combination with lenalidomide (Revlimid) and dexamethasone or with bortezomib (Velcade), melphalan, and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
- in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma.
- in combination with bortezomib, thalidomide (Thalomid), and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for ASCT.
- in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.
- in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received 1 prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least 2 prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy.
- as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
- as monotherapy for the treatment of adult patients with smoldering multiple myeloma at high risk of developing multiple myeloma.
- in combination with cyclophosphamide (Cytoxan), bortezomib, and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis.
“For more than 20 years, Johnson & Johnson has been dedicated to advancing care for people living with multiple myeloma. Despite advances in treatment, patients continue to face significant challenges, and we remain focused on supporting the community through ongoing research, innovation and collaboration with healthcare professionals,” Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head of Oncology at Johnson & Johnson, added in a news release.1 “Inspired by early real-world experiences, today’s milestone reflects our dedication to not only push the boundaries of science, but also to help ensure patients have access to treatment options that meet their evolving needs.”
Since its launch, daratumumab has been used for the treatment of more than 748,000 patients with multiple myeloma worldwide as of December 2025, according to Johnson & Johnson.
References
- Johnson & Johnson’s Darzalex (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers. News release. Johnson & Johnson. March 27, 2026. Accessed March 27, 2026. https://www.jnj.com/innovativemedicine/emea/media-center/press-releases/johnson-johnsons-darzalex-daratumumab-becomes-the-first-oncology-injectable-approved-for-administration-by-patients-or-caregivers
- Darzalex. Summary of produce characteristics. EMA. Accessed March 27, 2026. https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf
