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, aimed at treating adults with relapsed or refractory osteosarcoma who have not responded to at least two prior therapies. This designation is intended to speed up the development and review of drugs that could significantly improve treatment for severe conditions.
The decision is 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 over 60 participants with various bone and soft tissue sarcomas, showed promising early results, particularly for the 42 patients with osteosarcoma.
GSK’227 is a B7-H3-targeted antibody-drug conjugate (ADC) that delivers a topoisomerase inhibitor payload directly to cancer cells. The drug has also received regulatory designations from the European Medicines Agency and the FDA for its potential in treating extensive-stage small-cell lung cancer.
Osteosarcoma is a rare and aggressive bone cancer, predominantly affecting 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, especially after failing 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 ongoing global trials.
This announcement is based on a press release statement from GSK.
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