Genmab Secures FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S®) in Advanced Endometrial Cancer
Thursday, August 28, 2025
Genmab A/S has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for rinatabart sesutecan (Rina-S®). The investigational folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC) is being developed for adults with recurrent or progressive endometrial cancer (EC) whose disease has advanced following treatment with a platinum-based regimen and a PD-(L)1 therapy.
BTD is designed to accelerate the development and review of investigational medicines for serious or life-threatening conditions where early clinical evidence indicates a meaningful improvement over existing options.
The designation was supported by results from the Phase 1/2 RAINFOL™-01 trial (NCT05579366), which assessed Rina-S in solid tumours. In the monotherapy dose expansion B2 cohort, 64 patients with heavily pretreated advanced or recurrent EC, who had progressed on prior anti-PD-(L)1 and platinum-based chemotherapy, received Rina-S. These findings were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Rina-S is progressing through late-stage clinical development, including the ongoing Phase 1/2 RAINFOL-01 trial, the Phase 3 RAINFOL-02 trial (NCT06619236) in ovarian cancer, and several upcoming studies. A Phase 3 trial in endometrial cancer is also planned.
Source: businesswire.com
