FDA Approves Johnson & Johnson’s New Multiple Myeloma Therapy

1. FDA Approval for DARALEXASPRO:
- The FDA has approved Johnson & Johnson's DARALEXASPRO (daratumumab and hyaluronidase-fihj) for the initial treatment and consolidation of newly diagnosed multiple myeloma (NDMM) patients who are eligible for autologous stem cell transplantation (ASCT).
2. Clinical Trial Results:
- The approval is based on the Phase III PERSEUS study, which showed that the D-VRd regimen (daratumumab, bortezomib, lenalidomide, and dexamethasone) reduced the risk of disease progression or death by 60% compared to the VRd regimen, significantly enhancing progression-free survival.
3. CAR-T Cell Therapies:
- The FDA has also approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
4. Bispecific Antibody Therapy:
- TALVEY (talquetamab-tgvs), a bispecific antibody targeting the GPRC5D receptor, has been approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
5. Impact on Multiple Myeloma Treatment:
- These approvals expand treatment options for multiple myeloma patients, offering new hope for those with relapsed or refractory disease.