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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 3 days ago
- 1 min read
18/12/2025
BeOne Medicines' BGB-B2033 received the FDA fast track designation for HCC (Ref)
The US FDA granted the fast track designation to BeOne Medicines' BGB-B2033 (GPC3 x 4-1BB BsAb) for the treatment of adult patients with hepatocellular carcinoma (HCC) with disease progression on or after prior systemic treatment.
Julie Lepin, SVP and Chief Regulatory Affairs Officer, BeOne: “The FDA awards Fast Track Designation to therapies that show potential to address an unmet medical need in serious or life-threatening conditions. The FDA’s decision reflects the encouraging profile of BGB-B2033 in advanced hepatocellular carcinoma, where patients continue to face limited treatment options.”
BGB-B2033 is currently being evaluated in a global, multi-center Phase 1 NCT06427941 as monotherapy and in combination with tislelizumab (PD-1 inhibitor)
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