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News 2026-09-25 20:30 UTC

Daiichi Sankyo Company, Limited Withdraws U.S. BLA for I-DXd in ES-SCLC

Daiichi Sankyo voluntarily withdrew the U.S. accelerated approval BLA for ifinatamab deruxtecan in previously treated ES-SCLC after FDA said current data, including from phase 2 IDeate-Lung01, do not support approval. Enrollment continues in the phase 3 IDeate-Lung02 trial.Material DetailsContext b…