Johnson & Johnson has announced a landmark regulatory decision that will allow people living with multiple myeloma to administer the subcutaneous formulation of daratumumab themselves, or have it given by a caregiver, from the fifth dose.
The Committee for Medicinal Products for Human Use has approved a Type II variation to the medicine’s labelling, making it the first oncology injectable in Europe cleared for self‑administration.
The company said the update applies across all ten therapeutic indications for daratumumab in multiple myeloma, smouldering multiple myeloma and light chain amyloidosis. The change is intended to give patients and clinicians greater flexibility in how treatment is delivered.
Thomas Lund, Head of Hematological Section at Vejle Hospital and the University of Southern Denmark, said: “For many patients living with multiple myeloma, treatment can involve frequent hospital visits and the challenge of fitting care around everyday life. 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.”
He added: “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.”
Ester in ‘t Groen, EMEA Therapeutic Area Head Haematology at Johnson & Johnson, said: ‘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. 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.’
Yusri Elsayed, Global Therapeutic Area Head Oncology, added: “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.
“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.”
