FDA approves TECVAYLI plus DARZALEX FASPRO for myeloma after one prior line, a potential second-line standard

The FDA approved TECVAYLI (teclistamab) combined with DARZALEX FASPRO for adults with relapsed or refractory multiple myeloma who have had at least one prior line of therapy. The approval follows the Phase 3 MajesTEC-3 trial, where the combination cut the risk of progression or death by 83% (hazard ratio 0.17). Three-year progression-free survival was 83% versus 30% for the control arm, which is why J&J calls it a potential new standard of care as early as second line.

• Hazard ratio for progression-free survival 0.17 (95% CI 0.12-0.23) in MajesTEC-3
• Three-year progression-free survival 83% versus 30% in the control arm
• Approved for adults with at least one prior line, including a proteasome inhibitor and an immunomodulatory agent
• Company describes it as a potential new standard of care as early as second line