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GSK PLC on Tuesday said the US Food & Drug Administration has granted a breakthrough therapy designation to its treatment for a form of bone cancer. The London-based pharmaceuticals firm said its GSK5764227 treatment, a B7-H3-targeted antibody-drug conjugate, was in the process of being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma who have progressed on at least two prior lines of therapy. Osteosarcoma affects mostly children and young adults, accounting for 20% to 40% of all bone cancers, but less than 1% of all new cancer diagnoses. This is the third regulatory designation for the drug, following its priority medicines designation from the European Medicines Agency in August and the FDA’s breakthrough therapy designation for the treatment of small-cell lung cancer in December. The designation accelerates the development and review of drugs with the potential to treat a serious condition, based on preliminary evidence that shows substantial improvement over current available treatments. Global Head of Oncology Research & Development Hesham Abdullah said: ‘This latest regulatory designation for GSK’227 exemplifies the potential of our targeted ADC in patients with difficult to treat cancers. For patients with relapsed or refractory osteosarcoma, there is an urgent unmet medical need with no approved treatment options once the cancer returns a second time, and chemotherapy provides limited benefit in this setting.’ Shares in GSK were down 0.5% at 1,343.40 pence each in London on Tuesday morning. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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