FDA Grants Fast Track Designation to Nanjing Leads Biolabs’ Opamtistomig
The designation covers first-line advanced or metastatic biliary tract cancer. It is the program’s second Fast Track, and the FDA urged prompt talks on U.S. registration plans for the chemotherapy combination.
The FDA granted Fast Track Designation to opamtistomig, a PD-L1/4-1BB bispecific, for first-line advanced or metastatic biliary tract cancer. This is the program’s second Fast Track designation. S. registration plans for the chemotherapy combination.