Tag: interstitial lung disease

Daiichi Sankyo and Merck & Co/MSD have voluntarily withdrawn the Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd; DS-7300a), a B7-H3-directed antibody-drug conjugate (ADC), for adults with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

3rd Antibody-Drug Conjugate (ADC)  in Boston, MA, brought together a group of diverse yet deeply specialized experts who shared their knowledge, clinical insights, and technical experience with remarkable openness and clarity.