FDA granted breakthrough therapy designation to Enhertu (trastuzumab deruxtecan) for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
FDA has granted sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2 directed antibody-drug conjugate, a priority voucher via the agency’s Commissioner’s National Priority Voucher (CNPV) Pilot Program.
