US EditionAbbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC
- On May 26, 2025, Abbisko Therapeutics announced that irpagratinib received Breakthrough Therapy Designation from the CDE of the NMPA for treating Hepatocellular Carcinoma .
- The designation was granted based on encouraging early-stage clinical results in a patient population with advanced HCC characterized by FGF19 overexpression who have exhausted treatment with immune checkpoint and multikinase inhibitors.
- Abbisko shared clinical results indicating that administering 220mg irpagratinib twice daily alongside atezolizumab led to a 50% objective response rate in FGF19-positive hepatocellular carcinoma patients who had previously undergone immune checkpoint inhibitor therapy.
- Epidemiological data suggest that FGF19 is overexpressed in nearly one-third of hepatocellular carcinoma cases globally, a condition associated with poorer outcomes; Frost & Sullivan anticipates that irpagratinib will serve as the first transformative therapy targeting this patient subgroup.
- Abbisko has initiated a key clinical trial at Tongji Hospital and Nanjing Tianyinshan Hospital to accelerate the approval process and provide new therapeutic options for HCC patients exhibiting FGF19 overexpression.
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Abbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC
SHANGHAI, May 26, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China…
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Abbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC - PressReach
SHANGHAI, May 26, 2025 /PRNewswire/ — Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of Hepatocellular Carcinoma (HCC). Irpagratinib is the first therapeutic agent to le…
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