Johnson & Johnson Receives FDA Approval for Darzalex Faspro Subcutaneous Formulation

Johnson & Johnson today announced that the FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) subcutaneous formulation for all approved indications of intravenous daratumumab in multiple myeloma. The subcutaneous formulation can be administered in approximately 3-5 minutes compared to the multi-hour IV infusion. In the Phase 3 COLUMBA trial, Darzalex Faspro demonstrated comparable pharmacokinetics and efficacy to IV daratumumab. This approval provides patients with multiple myeloma a more convenient administration option for daratumumab-based therapy.