FDA Grants Fast Track Designation to GPC3x4-1BB Bispecific Antibody in HCC
The FDA has granted fast track designation to BGB‑B2033, a GPC3x4‑1BB bispecific antibody, as a treatment for adult patients with hepatocellular carcinoma (HCC) who experienced disease progression on or after prior systemic therapy.
BGB‑B2033 is under evaluation for patients with hepatocellular carcinoma who progressed on or after systemic therapy in a first‑in‑human phase 1 trial.
The FDA awards fast track designation to therapies that show potential to address an unmet medical need in serious or life‑threatening conditions.
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