FDA grants third CNPV-backed approval for Tec-Dara myeloma therapy

The FDA approved teclistamab with daratumumab hyaluronidase-fihj (Tec-Dara) for adults with relapsed/refractory multiple myeloma after at least one prior therapy, marking the third approval under the Commissioner's National Priority Voucher (CNPV) program; the Phase 3 trial showed an 83% reduction in the risk of disease progression or death and improvements in progression-free and overall survival versus standard of care, with Tec-Dara subject to a REMS due to risks such as cytokine release syndrome and immune effector cell–associated neurotoxicity (ICANS); the Tecvayli (teclistamab-cqyv) monotherapy indication will be converted from accelerated to traditional approval based on the same study.