Breakthrough designation for Genmab’s Rina-S in USA

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Rina-S (rinatabart sesutecan), Genmab’s (CPH: GMAB) folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC), for adults with recurrent or progressive endometrial cancer (EC) 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 I/II RAINFOL-01 trial, evaluating the safety and efficacy of Rina-S in solid tumors.