Posted by Michael Wonder on 08 Nov 2024
Johnson & Johnson submits applications in the US and EU seeking approval of Darzalex Faspro/Darzalex as subcutaneous monotherapy for high risk smoldering multiple myeloma
8 November 2024 - If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at high risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage.
Johnson & Johnson today announced the submission of regulatory applications to the US FDA and EMA seeking approval of a new indication for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in the US and Darzalex subcutaneous formulation in the European Union.
