Merck and Daiichi Sankyo withdrew their BLA for ifinatamab deruxtecan (i-dxd), a B7-H3-directed ADC for extensive-stage small-cell lung cancer, ahead of its October PDUFA date. The change removes one key FDA decision from the near-term schedule and affects accelerated-approval planning tied to the program. The withdrawal follows the broader pattern of ADC development timelines being reshaped by regulatory and trial-data expectations in fast-moving oncology subsets, leaving remaining FDA decision slots concentrated among other programs. For biotech operators, the episode reinforces how quickly ADC timelines can shift when sponsors reassess regulatory positioning close to milestone dates.