Core Viewpoint - The FDA has granted Fast Track Designation (FTD) to Irpagratinib (ABSK-011), a selective FGFR4 inhibitor developed by the company, for the treatment of advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have previously received immune checkpoint inhibitors (ICI) and multi-targeted kinase inhibitors (mTKI) [1][3][4]. Group 1: FDA Fast Track Designation - The Fast Track Designation aims to expedite the development and review process of innovative therapies for serious diseases with unmet clinical needs, allowing for earlier and more frequent communication with the FDA [3]. - The designation will accelerate global clinical development and registration processes for Irpagratinib, potentially shortening the time to market [3][4]. Group 2: Clinical Data and Efficacy - In a Phase I clinical study presented at the 2024 ESMO annual meeting, Irpagratinib demonstrated an objective response rate (ORR) of 46.7% and a median progression-free survival (mPFS) of 5.5 months in HCC patients with FGF19 overexpression who had progressed after ICI and mTKI treatments [4]. - The safety and tolerability profile of Irpagratinib was reported to be favorable, showing significant advantages over previous treatment data for HCC patients [4]. Group 3: Combination Therapy Exploration - The company is also exploring combination therapy with Irpagratinib and Roche's PD-L1 inhibitor Atezolizumab, which has shown an ORR exceeding 50% and mPFS over 7 months in both treatment-naive and previously treated HCC patients with FGF19 overexpression [4]. - No new safety signals were observed in the combination therapy, suggesting a potential synergistic mechanism between FGFR4 inhibitors and ICIs [4]. Group 4: Precision Oncology Shift - Irpagratinib represents a significant shift towards precision oncology in the treatment of liver cancer, aligning with global trends in molecularly driven precision therapies [5]. - The development of Irpagratinib aims to establish a new treatment paradigm for patients with FGF19 overexpression, promoting a more targeted approach in HCC treatment [5].
和誉医药依帕戈替尼获FDA快速通道资格，国际权威媒体OncoDaily发文报道