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GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma

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  • The US FDA has granted BTD to GSK5764227 (GSK’227) for treating r/r osteosarcoma in patients with disease progression on at least 2 prior lines of therapy
  • Designation was supported by P-II (ARTEMIS-002) trial (carried out by Hansoh Pharma) assessing the safety & efficacy of GSK’227 to treat patients (n=60; 42 had osteosarcoma) with r/r osteosarcoma plus other unresectable bone & soft tissue sarcomas. Results were highlighted at ASCO 2024
  • GSK’227 (HS-20093) is a B7-H3-targeted ADC developed by Hansoh Pharma for various solid tumors. In 2023, GSK acquired global rights (excl. China’s mainland, Hong Kong, Macau & Taiwan) for its development & launched a global P-I trial in Aug 2024

Ref: GSK | Image: GSK

Related News:- GSK’s GSK’227 Secures the EMA’s Priority Medicines (PRIME) Designation for Extensive-Stage Small-cell Lung Cancer

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