Johnson & Johnson Seeks FDA Approval for DARZALEX FASPRO® Combo in Multiple Myeloma
Johnson & Johnson has submitted a supplemental Biologics License Application to the U.S. FDA, seeking approval for a DARZALEX FASPRO®-based regimen combined with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients. This submission follows the positive outcomes from the Phase 3 CEPHEUS study, which showcased the regimen's effectiveness in achieving a 60.9% minimal residual disease (MRD) negativity rate and a 43% reduction in progression or death risk, compared with the standard VRd regimen[1][2]. The study, presented at the 2024 International Myeloma Society Annual Meeting, reported an overall complete response rate of 81.2% in the D-VRd group versus 61.6% in the VRd group, establishing a new potential standard of care with enhanced safety profiles[1].
References
- Johnson & Johnson files for U.S. FDA approval of DARZALEX FASPRO®-based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned
- DARZALEX FASPRO®-based quadruplet regimen significantly improves minimal residual disease negativity for newly diagnosed multiple myeloma patients for whom transplant is not planned
Explore Further
What are the potential implications of DARZALEX FASPRO®'s FDA approval on the standard treatment protocols for multiple myeloma?
How does the quadruplet regimen D-VRd compare cost-wise to existing VRd treatments for multiple myeloma?
What are the specific side effects reported in the Phase 3 CEPHEUS study for the DARZALEX FASPRO® regimen?
How does Johnson & Johnson plan to address the availability and distribution challenges if DARZALEX FASPRO® is approved?
What role did minimal residual disease negativity play in the success of the DARZALEX FASPRO® combination regimen?