GSK’s Risvutatug Rezetecan Secures the US FDA’s Orphan Drug Designation for Treating SCLC
Shots:
- The US FDA has granted ODD to GSK’s risvutatug rezetecan (GSK5764227) for the treatment of small-cell lung cancer (SCLC)
- Designation was supported by preliminary P-I (ARTEMIS-001) trial data showing durable responses in pts with extensive-stage SCLC treated with risvutatug rezetecan
- GSK’227 is a B7-H3-targeted ADC developed by Hansoh Pharma for various solid tumors. GSK acquired global rights (excl. Mainland China, Hong Kong, Macau & Taiwan) for its development & launched a global P-III trial in Aug 2025 for relapsed ES-SCLC
Ref: GSK | Image: GSK |Press Release
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