FDA Approves Subcutaneous TECVAYLI Plus Darzalex Faspro After MajesTEC-3 Shows 83% Risk Reduction
Johnson & Johnson received FDA approval for subcutaneous TECVAYLI plus DARZALEX FASPRO to treat adults with relapsed/refractory multiple myeloma who have had at least one prior therapy. Phase 3 MajesTEC-3 data showed an 83% reduction in progression or death risk (HR 0.17) and an 83% three-year PFS rate.
1. FDA Approval Details
Johnson & Johnson secured FDA approval for the combination of subcutaneous TECVAYLI (teclistamab-cqyv) and DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in adults with relapsed or refractory multiple myeloma after at least one prior therapy. This regimen is administered entirely via subcutaneous injection across all care settings.
2. Phase 3 MajesTEC-3 Outcomes
The approval is based on data from the ongoing Phase 3 MajesTEC-3 trial, which compared TECVAYLI plus DARZALEX FASPRO to investigator’s choice regimens. Results demonstrated a hazard ratio of 0.17 for progression or death (83% risk reduction) and an 83% progression-free survival rate at three years.
3. Financial and Strategic Impact
Halozyme’s ENHANZE delivery technology underpins the subcutaneous formulation, positioning the company to earn royalties on product sales. The approval expands ENHANZE’s reach within multiple myeloma and strengthens Halozyme’s growth outlook in biologic delivery solutions.