Merck and Daiichi withdraw US filing for lung cancer ADC

28 September 2026

US pharma major Merck & Co (NYSE: MRK) and Japanese drugmaker Daiichi Sankyo (TYO: 4568) have voluntarily withdrawn their application for accelerated US approval of ifinatamab deruxtecan (I-DXd), following feedback from the US regulator, the Food and Drug Administration (FDA).

The B7-H3-directed antibody-drug conjugate (ADC) was seeking approval for adults with extensive-stage small-cell lung cancer whose disease had progressed on or after platinum-based chemotherapy.

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