Cancer NetworkOriginal article
<![CDATA[FDA Discussion Prompts Voluntary Withdrawal of BLA for I-DXd in ES-SCLC]]>
BLA FilingrejectedI-DXdNegative
AI Analysis
Summary
Daiichi Sankyo voluntarily withdrew its BLA for I-DXd in relapsed ES-SCLC following an FDA discussion. The phase 3 IDeate-Lung02 trial comparing I-DXd to chemotherapy will continue enrolling patients.
Clinical Trial Data
Phase
3
Outcome Details
Voluntary withdrawal of BLA following FDA discussion
Importance:7/10
Sentiment:
-0.70
FDABLAwithdrawalES-SCLCPhase 3
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Published by Cancer Network on October 1, 2026 4:00 PM