Tag: I-DXd

Daiichi Sankyo and Merck & Co/MSD have voluntarily withdrawn the Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd; DS-7300a), a B7-H3-directed antibody-drug conjugate (ADC), for adults with previously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.

B7-H3 Antibody-Drug Conjugates Gain Momentum as Frontline Standards Shift Across Solid Tumors

Merck & Co (known as MSD outside of the United States and Canada) and Daiichi Sankyo have entered into a global development and commercialization agreement for the jointly development of three of Daiichi Sankyo’s DXd antibody-drug conjugate (ADC) candidates.  The selected ADCs include patritumab deruxtecan (U3-1402/HER3-DXd), ifinatamab deruxtecan (DS-7300a/I-DXd) and raludotatug deruxtecan (DS-6000a/R-DXd).