GSK’s GSK5764227 (GSK’227) Gets the US FDA’s Breakthrough Therapy Designation for r/r Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)
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- The US FDA has granted BTD to GSK’227, a B7-H3-targeted ADC, for ES-SCLC with disease progression on or after Pt-based CT, and GSK holds exclusive development and commercialization rights worldwide (excluding China) from Hansoh Pharma
- The BTD was based on early clinical evidence from the P-I (ARTEMIS-001) study assessing safety, tolerability & preliminary anti-tumor activity in r/r ES-SCLC individuals (n>200), conducted by Hansoh Pharma
- GSK’227 aka. HS-20093 is now being developed by Hansoh Pharma. An ongoing P-I/II study for various solid tumors in China. Additionally, GSK plans to initiate a P-I/II global study in H2’24 to support a registrational pathway for GSK’227
Ref: GSK | Image: GSK
Related News:- GSK Reports the US FDA’s Expanded Approval of Jemperli Plus Chemotherapy for Treating Endometrial Cancer
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
