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B7-H3 ADC US FDA Breakthrough Therapy Designation
B7-H3 ADC US FDA Breakthrough Therapy Designation.
About this update from Gsk Plc
[{"type":"text","content":"\n\nIssued: 20 August 2024, London UK\n \nGSK receives US FDA Breakthrough Therapy Designation for its B7-H3-targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer\n \n\nRegulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type\n\nBreakthrough Therapy Designation aims to expedite development and review of drugs with potential to show improvement over available therapies for serious conditions\n\nPatients with this aggressive form of lung cancer who experience disease progression on or after chemotherapy have limited treatment options that typically result in poor outcomes\n\n \n \nGSK plc (LSE/NYSE: GSK) announced today 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.[1]\n\nHesham 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. Today's 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.”\n \nLung cancer is one of the most common cancers worldwide. In the US, approximately 15% of all lung cancers are small-cell. Of patients with small-cell lung cancer, 70% have extensive-stage disease meaning the cancer has spread throughout one or both lungs and/or to other parts of the body[2]. ES-SCLC is an aggressive and difficult-to-treat cancer with limited treatment options. The 5-year survival rate is approximately 3%2. Most patients with ES-SCLC relapse after initial treatment and the median overall survival with current standa...