BRIEF—FDA Breakthrough status for GSK’227 in osteosarcoma

UK pharma major GSK today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for GSK5764227 (GSK’227), its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) 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 grant of Breakthrough Therapy designation for relapsed or refractory extensive-stage small-cell lung cancer in August 2024 and December 2024, respectively.

The FDA designation is supported by data from the ARTEMIS-002 study. This is a phase II, open-label, randomized, multicenter, clinical trial evaluating the efficacy and safety of GSK’227 in patients with relapsed or refractory osteosarcoma and other unresectable bone and soft tissue sarcomas, conducted by Hansoh Pharma.