The United States Food and Drug Administration (FDA) approved teclistamab-cqyv (TECVAYLI®) plus daratumumab and hyaluronidase-fihj (DARZALEX FASPRO®) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.
The approval is based on data from the phase 3 MajesTEC-3 study, which demonstrated that the combination had significant improvements in progression-free survival and overall survival compared with the standard of care. The study found the treatment reduced the risk of disease progression or death by 83.3% relative to the control arm, according to the manufacturer’s press announcement.
This approval is the third approval granted through the Commissioner’s National Priority Voucher pilot program. The FDA issued the decision within two months of filing to prioritize innovative therapies that address large unmet medical needs and increase affordability.
