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 Johnson & Johnson’s 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.

 With this label update, patients and their healthcare professionals can work together to decide the most suitable choice of administration.1 It applies to all ten therapeutic indications of daratumumab SC for multiple myeloma, smouldering multiple myeloma and light chain (AL) amyloidosis.

Thomas Lund, M.D., Ph.D., Head of Hematological Section, Department of Medicine, Vejle Hospital, Department of Regional Health Research, 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. 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, 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.”