Shots:
- FDA has accepted BLA for I-DXd under the RTOR & Project Orbis program, granting priority review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after Pt-based CT (PDUFA: Oct 10, 2026)
- BLA was based on the P-II (IDeate-Lung01) study assessing I-DXd (IV, Q3W) in ES-SCLC pts (n=187) previously treated with 1-3L of therapies, randomized to receive 8mg/kg or 12mg/kg in part 1, & 12mg/kg in part 2, with support from the P-I/II (IDeate-PanTumor01) trial (n=~250)
- Primary analysis of IDeate-Lung01 was presented at the WCLC’25 & published in The JCO, while I-DXd received US FDA Breakthrough Therapy Designation in Aug 2025 for ES-SCLC post Pt-based chemotherapy
Ref: Merck | Image: Merck & Daiichi Sankyo | Press Release
Related News: Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
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