NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced Friday 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.
Patients and their healthcare professionals can now work together to decide the most suitable choice of administration. It applies to all ten therapeutic indications of daratumumab SC for multiple myeloma, smouldering multiple myeloma and light chain (AL) amyloidosis.
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