Merck, Daiichi Sankyo Withdraw FDA Application for Ifinatamab Deruxtecan in Lung Cancer
- Merck & Co. and Daiichi Sankyo voluntarily withdrew their FDA BLA for ifinatamab deruxtecan, a B7-H3-targeted ADC, in previously treated ES-SCLC.
- FDA feedback indicated Phase 2 data didn't support accelerated approval, marking the alliance's second pullback for the drug after an earlier lung-toxicity-related clinical hold.
- The companies continue the Phase 3 IDeate-Lung02 confirmatory trial and other Phase 3 studies in prostate and esophageal cancer.
💡 Points
A second stumble for the same molecule is a real signal, but it's about ifinatamab deruxtecan's timeline, not the Merck-Daiichi deal's overall health — this alliance is bigger than one BLA. Withdrawing rather than fighting for a contested approval is the disciplined move, protecting IDeate-Lung02's confirmatory data package. But every added year gives rival B7-H3 ADC programs room to catch up.
Merck, Daiichi scrap FDA application for B7-H3 ADC in lung cancer ↗