Genmab receives FDA Breakthrough Therapy Designation for rinatabart sesutecan

Genmab (GMAB) announced that the FDA has granted Breakthrough Therapy Designation to rinatabart sesutecan, an investigational folate receptor alpha-directed, TOPO1-inhibitor 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-1 therapy. BTD aims to expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.