Johnson & Johnson (JNJ) has announced that the U.S. Food and Drug Administration has approved Darzalex Faspro, a combination of daratumumab and hyaluronidase-fihj, for use alongside bortezomib, lenalidomide, and dexamethasone (D-VRd). This regimen is intended for the induction and consolidation treatment of patients newly diagnosed with multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).
The approval is based on data from the Phase 3 PERSEUS study, which evaluated Darzalex Faspro in a D-VRd induction and consolidation therapy against a regimen of bortezomib, lenalidomide, and dexamethasone (VRd) during the same treatment phases in NDMM patients suitable for ASCT.
