GSK secures USFDA Breakthrough Therapy Designation for GSK5764227 for extensive stage small cell lung cancer
London: GSK plc has 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 (relapsed or refractory). 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.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said, “Extensive-stage small-cell lung cancer is aggressive with poor prognosis and significant need for new treatments. The Breakthrough Therapy Designation supports our ambition to accelerate GSK’227 for these patients as part of our broader ADC programme focused on developing new treatment options with transformational and first-to-market potential.”
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