Posted by Michael Wonder on 27 Aug 2025
Genmab receives FDA breakthrough therapy designation for rinatabart sesutecan in advanced endometrial cancer
t26 August 2025 - Genmab announced today that the US FDA has granted breakthrough therapy designation to rinatabart sesutecan, an investigational folate receptor alfa directed, TOPO1inhibitor antibody drug conjugate, for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
The designation was supported by previously published results from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part, Phase 1/2 RAINFOL-01 trial, evaluating the safety and efficacy of rinatabart sesutecan in solid tumours.
