DARZALEX® Becomes First Oncology Injectable Approved – HPN

DARZALEX® Becomes First Oncology Injectable Approved for Self-Administration in Europe

Johnson & Johnson has announced European approval for eligible multiple myeloma patients or caregivers to self-administer DARZALEX® from the fifth dose onwards.

Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved a Type II variation to the labelling of DARZALEX® (daratumumab) subcutaneous formulation, enabling eligible patients or caregivers to administer the treatment from the fifth dose onwards following appropriate training and clinical assessment.

The decision marks the first oncology injectable approved for self-administration by patients or caregivers in Europe.