Overview
- The designation makes the teclistamab plus daratumumab regimen the 16th recipient under the FDA’s Commissioner’s National Priority Voucher pilot program.
- The award is backed by phase 3 MajesTEC‑3 results presented at ASH and published in the New England Journal of Medicine.
- In the trial, median progression‑free survival was not reached versus 18.1 months for control (HR 0.17), with 36‑month PFS rates of 83.4% versus 29.7%.
- Response and survival endpoints favored the combination, including ORR 89.0% versus 75.3%, CR or better 81.8% versus 32.1%, MRD negativity 58.4% versus 17.1%, and an OS benefit (HR 0.46).
- Safety findings included universal TEAEs and high rates of grade 3/4 events, with cytokine release syndrome in 60.1% that was mostly grade 1 and resolved without grade 3 or higher cases.