Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a regulatory study for its novel small-molecule FGFR4 inhibitor, irpagratinib.
Details of the Approved Trial
The approved trial, ABSK-011-205, is a multi-center, randomized, double-blinded study designed to assess the efficacy and safety of irpagratinib in combination with Best Supportive Care (BSC) compared to placebo combined with BSC. The study will focus on FGF19-overexpressing advanced or unresectable hepatocellular carcinoma (HCC) patients who have previously been treated with immunotherapy and multi-target tyrosine kinase inhibitors (mTKIs). The results of this study will serve as a key basis for the drug’s potential market filing approval.
Irpagratinib’s Potential Impact
Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko, holds global intellectual property rights. It targets the aberrant activation of the FGF19-FGFR4 signaling pathway, which occurs in approximately 30% of HCC patients and is known to drive tumor growth. With no similar drug approved worldwide, irpagratinib has the potential to become the first FGFR4 inhibitor for FGF19-overexpressing HCC, offering a new treatment option for patients in need.-Fineline Info & Tech
