Janssen's TECVAYLI® and DARZALEX FASPRO® Join FDA's Priority Voucher Program
- TECVAYLI® and DARZALEX FASPRO® demonstrate significant progression-free and overall survival in multiple myeloma.
- The Phase 3 MajesTEC-3 study supports their use as a potential second-line standard of care.
- The FDA granted Breakthrough Therapy Designation and is reviewing the sBLA through the RTOR program.
- TECVAYLI® received accelerated FDA approval in October 2022 for relapsed or refractory multiple myeloma.
FDA Priority Voucher Program
The U.S. FDA has selected the teclistamab MajesTEC-3 supplemental Biologics License Application (sBLA) for the Commissioner’s National Priority Voucher Pilot Program. This aligns with the program's goal to deliver innovative therapies to the American public.
Clinical Study Results
The Phase 3 MajesTEC-3 study demonstrated that TECVAYLI® (teclistamab-cqyv) combined with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) significantly improved progression-free survival and overall survival in patients with relapsed/refractory multiple myeloma compared to standard treatments. These findings were presented at the American Society of Hematology Annual Meeting and published in The New England Journal of Medicine.
Regulatory Approvals
The FDA has granted the TECVAYLI® and DARZALEX FASPRO® combination a Breakthrough Therapy Designation and is reviewing the sBLA through the Real-Time Oncology Review program. TECVAYLI® received accelerated FDA approval in October 2022 for use in adult patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy.
Study Details
The ongoing MajesTEC-3 study is a Phase 3 randomized trial evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib. The primary endpoint is progression-free survival, with secondary endpoints including overall response rate, minimal residual disease negativity, and safety.
Source: J&J