BioPharma DiveOriginal article
Merck, Daiichi end plans to seek speedy approval of lung cancer ADC
RegulatorynegativeI-DXdNegative
AI Analysis
Summary
Merck and Daiichi Sankyo have abandoned their plans to seek accelerated FDA approval for the lung cancer antibody-drug conjugate I-DXd after FDA feedback indicated the clinical data generated would not support an expedited clearance pathway.
Outcome Details
FDA indicated data would not support accelerated clearance; companies ended pursuit of speedy approval pathway
Importance:7/10
Sentiment:
-0.75
ADClung canceraccelerated approvalFDA feedbackregulatory setback
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Published by BioPharma Dive on September 28, 2026 12:52 PM