GSK’s GSK’227 receives FDA BTD for treating adults with relapsed osteosarcoma

GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for GSK5764227, GSK’227, its B7-H3-targeted antibody-drug conjugate being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma who have progressed on at least two prior lines of therapy. This is the third regulatory designation for GSK’227, following the European Medicines Agency’s decision to grant Priority Medicines, PRIME, designation and the FDA’s decision to grant Breakthrough Therapy Designation for relapsed or refractory extensive-stage small-cell lung cancer in August 2024 and December 2024, respectively.