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Johnson & Johnson’s DARZALEX (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers

March 27, 2026 – Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Pharmaceutical – CHMP, EMA, Injectable Drugs, Johnson & Johnson, approvals, multiple myeloma, oncology, oncoloy

Landmark decision by CHMP grants approval for self or caregiver administration for patients living with multiple myeloma
Milestone is a testament to ten years of daratumumab experience and innovation, continuing to transform multiple myeloma care

27 March 2026 — Beerse, Belgium — 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. This landmark decision makes daratumumab the first oncology injectable approved for self-administration in Europe.

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. It applies to all ten therapeutic indications of daratumumab SC for multiple myeloma, smouldering multiple myeloma and light chain (AL) amyloidosis.

“For many patients living with multiple myeloma, treatment can involve frequent hospital visits and the challenge of fitting care around everyday life,” said Thomas Lund, M.D., Ph.D., Head of Hematological Section, Department of Medicine, Vejle Hospital, Department of Regional Health Research, University of Southern Denmark. “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.”

Building on a decade of innovation with daratumumab

“Daratumumab has played a transformative role in the treatment of multiple myeloma and has become a foundational therapy across the disease continuum since its first approval nearly a decade ago,” said Ester in ‘t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson. “Today we are proud to continue innovating with daratumumab, and this label update marks the first European approval of an anti-cancer injectable for self-administration.”

“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,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “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.”

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. Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. Daratumumab may also have an effect on normal cells. 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.

For further information on daratumumab, please see the Summary of Product Characteristics at:
ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com/innovativemedicine/emea/.