Genmab receives FDA Breakthrough Therapy Designation for Rinatabart sesutecan (Rina-S) in advanced endometrial cancer (EC)

CAR-T Digest - August 2020

26 August 2025: Genmab receives FDA Breakthrough Therapy Designation for Rinatabart sesutecan (Rina-S) in advanced endometrial cancer (EC)

The FDA granted Breakthrough Therapy Designation to Genmab’s rinatabart sesutecan (Rina-S) for recurrent or progressive endometrial cancer in patients previously treated with platinum-based chemotherapy and PD-(L)1 therapy
The designation is based on Phase 1/2 RAINFOL-01 trial results, which showed encouraging responses in 64 heavily pretreated EC patients presented at ASCO 2025
Rina-S is a folate receptor alpha (FRα)-directed, TOPO1-inhibitor ADC designed to deliver improved efficacy with targeted precision in solid tumors
Genmab plans to further evaluate Rina-S in a Phase 3 trial for endometrial cancer, in addition to its ongoing development in ovarian and other cancers
The recognition highlights Genmab’s strategy to expand its ADC portfolio and address significant unmet needs in gynecologic cancers with innovative antibody-based therapies