TECVAYLI® plus DARZALEX FASPRO® combination selected for Commissioner’s National Priority Voucher Pilot program
U.S. Food and Drug Administration (FDA) has selected the teclistamab MajesTEC-3 supplemental Biologics License Application (sBLA) to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program. The sBLA is based on the Phase 3 MajesTEC-3 results, which showed TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated a statistically significant progression-free survival (PFS) and overall survival advantage compared to standard treatment after three years in patients with relapsed/refractory multiple myeloma.
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