FDA Grants Fast Track Designation to Opamtistomig for Advanced Biliary Tract Cancer

The FDA has granted fast track designation to opamtistomig, a PD-L1/4-1BB bispecific antibody, for first-line treatment of advanced or metastatic biliary tract cancer based on promising phase 2 trial data from China showing safety and preliminary efficacy. This is opamtistomig's second FDA fast track designation, signaling accelerated regulatory engagement for registration in the US.

This Wire brief sits within Fusion42's coverage of Biotech.