Posted by Michael Wonder on 12 Nov 2020
Janssen submits applications in U.S. and EU seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj)/Darzalex (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma
12 November 2020 - Applications supported by positive results from the Phase 3 APOLLO trial, which demonstrated longer progression-free survival in patients receiving the subcutaneous formulation of daratumumab.
Janssen announced today the submission of regulatory applications to the U.S. FDA and EMA seeking approval of the daratumumab subcutaneous (SC) formulation, known as Darzalex (daratumumab and hyaluronidase-fihj) in the U.S. and as Darzalex SC in the European Union.
The applications seek approval of the combination of Darzalex Faspro/Darzalex SC in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
