GSK Plc. (GSK,GSK.L) announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation for GSK5764227, the company's investigational B7-H3-targeted antibody drug conjugate being evaluated for the treatment of patients with extensive-stage small-cell lung cancer 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.
The FDA's Breakthrough Therapy Designation is supported by data from the ongoing ARTEMIS-001 Phase 1 open-label, multi-center trial of more than 200 patients evaluating the safety, tolerability, and preliminary anti-tumor activity in locally advanced or metastatic solid tumors, including relapsed or refractory extensive-stage small-cell lung cancer, conducted by Hansoh Pharma.
Earlier this year, GSK acquired exclusive worldwide rights (excluding China's mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialization of GSK5764227.
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