The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved Darzalex® (daratumumab) for a Type II variation labeling, which allows myeloma patients or their caregivers to administer the drug from the fifth dose, "if determined to be appropriate by their healthcare professional and following proper training."

On Friday, March 27, Johnson & Johnson announced via press release 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," Johnson & Johnson further stated.

“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," 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.

This label update helps patients and their healthcare providers choose the most appropriate way to receive treatment. It applies to all ten approved uses of subcutaneous daratumumab for multiple myeloma, smoldering multiple myeloma, and light chain (AL) amyloidosis.

For further information on daratumumab, view or download the EMA's Summary of Product Characteristics.

 

References:
Johnson & Johnson’s DARZALEX® (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers. Johnson & Johnson press release. March 27, 2026.

Darzalex (daratumumab):Summary of Product Characteristics. European Medicines Agency.