FDA Grants Fast Track Designation for Opamtistomig in Biliary Tract Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, for the first-line treatment of advanced or metastatic biliary tract cancer (BTC). This is the second Fast Track Designation for opamtistomig, highlighting its potential to address unmet medical needs in this patient population and streamline its development and registration pathway.