ABBISKO-B (02256) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its self-developed highly selective small-molecule FGFR4 inhibitor Irpagratinib (also known as ABSK-011). The designation applies to the treatment of hepatocellular carcinoma (HCC) patients who have previously received immune checkpoint inhibitors and multi-target kinase inhibitors and exhibit FGF19 overexpression. This FDA designation will help accelerate the global clinical development and regulatory review process for Irpagratinib. ABBISKO-B will continue to advance the international clinical deployment of this project, aiming to provide more precise and effective innovative treatment options for HCC patients worldwide.
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