19 July 2019 - Data supporting the application demonstrated that the investigational subcutaneous formulation improved quality of life, reduced administration time, lowered rates of infusion-related reactions, and was non-inferior compared to intravenous administration.

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of an extension application to the EMA for subcutaneous use of Darzalex (daratumumab) for the treatment of patients with multiple myeloma. 

This subcutaneous formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's Enhanze drug delivery technology]. Daratumumab is currently only approved for intravenous (IV) use.

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