Sponsors halted recruitment and enrollment in a phase III study of the antibody‑drug conjugate (ADC) ifinatamab deruxtecan after a higher‑than‑anticipated incidence of fatal interstitial lung disease (grade 5 ILD). Daiichi Sankyo announced the voluntary partial hold; regulatory authorities including the U.S. FDA placed partial holds while safety data are reviewed by an independent data monitoring committee. The pause affects multiple countries and activates a safety review with regulators and the trial’s independent monitors. Sponsors will provide updates after safety adjudication and any protocol modifications; the hold underscores ongoing safety risks in the ADC class and the need for enhanced ILD surveillance in lung‑cancer programs.
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