LONDON – GSK plc (LSE/NYSE: GSK) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational drug GSK’227, for the treatment of adults with relapsed or refractory osteosarcoma who have not responded to at least two prior therapy. This designation aims to speed up the development and review of drugs that could significantly improve the treatment of serious conditions.
The decision was supported by data from the ARTEMIS-002 study, a phase II clinical trial evaluating the efficacy and safety of GSK’227 in patients with osteosarcoma. The trial, which included more than 60 participants with a variety of bone and soft tissue sarcomas, showed promising early results, particularly for 42 patients with osteosarcoma.
GSK’227 is a B7-H3-targeted antibody-drug conjugate (ADC) that delivers a topoisomerase inhibitor payload directly into cancer cells. The drug has also received regulatory designations from the European Medicines Agency and the FDA for its potential in the treatment of extensive-stage small cell lung cancer.
Osteosarcoma is a rare and aggressive bone cancer, which predominantly affects children and young adults. It accounts for 20-40% of all bone cancers, with an annual incidence of 3.3 patients per million in the US. Treatment options for those with relapsed or refractory osteosarcoma are limited, particularly after failure of two lines of therapy, highlighting the urgent need for new therapeutic options.
GSK, known for its focus on oncology and commitment to improving patient survival, has acquired exclusive worldwide rights to further develop and commercialize GSK’227, with global trials underway.
This announcement is based on a GSK press release.
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