GSK receives U.S. FDA Breakthrough Therapy Design for GSK5764227

GSK (GSK) announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation for GSK5764227, GSK’227, the Company’s investigational B7-H3-targeted antibody drug conjugate, ADC, being evaluated for the treatment of patients with extensive-stage small-cell lung cancer, ES-SCLC, with disease progression on or after platinum-based chemotherapy. The Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy. Earlier this year, GSK acquired exclusive worldwide rights from Hansoh Pharma (HNSPF) to progress clinical development and commercialisation of GSK’227. FDA’s Breakthrough Therapy Designation is supported by data from the ongoing ARTEMIS-001 Phase 1 open-label and preliminary anti-tumour activity in locally advanced or metastatic solid tumours.