Posted by Michael Wonder on 28 Mar 2026
Johnson & Johnson’s Darzalex (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers
27 March 2026 - Johnson & Johnson today announced that the CHMP of the EMA has granted approval for a Type II variation to the labelling for Darzalex (daratumumab) subcutaneous 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 health care professional and following proper training. This landmark decision makes daratumumab the first oncology injectable approved for self-administration in Europe.
