Tag: tetrapeptide-based cleavable linker
Daiichi Sankyo and Merck & Co/MSD Withdraw BLA for Ifinatamab Deruxtecan...
Daiichi Sankyo and Merck & Co/MSD have voluntarily withdrawn the Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd; DS-7300a), a B7-H3-directed antibody-drug conjugate (ADC), for adults with previously treated extensive-stage small cell lung cancer (ES-SCLC). The withdrawal follows discussions with the U.S. Food and Drug Administration (FDA), which concluded that the data submitted with the application, including results from the Phase 2 IDeate-Lung01 trial, did not satisfy the requirements for accelerated approval in the proposed indication.
US FDA Approved Datopotamab Deruxtecan as first TROP2 Directed Therapy for...
Datopotamab deruxtecan (datopotamab deruxtecan-dlnk in the U.S. only; Datroway®; Daiichi Sankyo and AstraZeneca; see ADC Drug Map) has been approved by the U.S. Food and Drug Administration (FDA)
