GSK’s GSK5764227 (GSK’227) Gets the US FDA’s Breakthrough Therapy Designation for r/r Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)
Shots:
- 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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
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. He can be contacted at connect@pharmashots.com
