Johnson & Johnson has received a key regulatory endorsement in Europe, marking a significant shift in how oncology treatments can be administered. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has approved a Type II variation to the label of DARZALEX (daratumumab) subcutaneous (SC) formulation. This update allows patients diagnosed with multiple myeloma, or their caregivers, to administer the therapy from the fifth dose onward, provided this approach is deemed suitable by a healthcare professional and appropriate training has been completed. The decision establishes DARZALEX self-administration as the first instance of an oncology injectable being approved for patient or caregiver use in Europe.
The DARZALEX self-administration approval introduces a new level of flexibility into treatment pathways. Patients and clinicians can now jointly determine the most appropriate administration setting, whether in clinical environments or at home. The updated label applies across all ten therapeutic indications of daratumumab SC, covering multiple myeloma, smouldering multiple myeloma, and light chain (AL) amyloidosis. This expanded flexibility is expected to ease the logistical burden associated with frequent hospital visits, while maintaining established standards of safety and efficacy.
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.
The approval builds on nearly a decade of clinical and real-world experience 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.
