The China National Medical Products Administration鈥檚 (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation approval to Abbisko Therapeutics鈥� fibroblast growth factor receptor 4 (FGFR4) small molecule inhibitor, irpagratinib, for treating hepatocellular carcinoma (HCC).
The therapy claims to be the first therapeutic agent to utilise molecularly defined biomarkers for precision-targeted HCC treatment.
The CDE鈥檚 decision is supported by encouraging data from the Phase I trial, indicating the potential of the therapy to fill a treatment void for individuals with advanced or unresectable HCC, who have limited options after undergoing immune checkpoint inhibitor (ICI)- and multitargeted tyrosine kinase inhibitor (mTKI)-based treatments.
Specifically, those with overexpression of FGF19, linked to a worse prognosis, stand to benefit from this new treatment approach.
The designation is expected to accelerate the regulatory process for the therapy, offering hope to patients with HCC.
Abbisko has already initiated a pivotal registrational clinical trial of the therapy at Tongji Hospital and Nanjing Tianyinshan Hospital, targeting HCC subjects with overexpression of FGF19.
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By GlobalDataIrpagratinib’s mechanism of action involves the targeting of the FGF19 signalling pathway, which is overexpressed in nearly 30% of HCC subjects globally.
Moreover, the company is conducting a Phase II trial of irpagratinib in conjunction with an anti-programmed death ligand 1 (PD-L1) antibody, atezolizumab from F. Hoffmann-La Roche and Roche (China).
According to the clinical data presented by the company previously, this combination of 220mg of irpagratinib twice daily and atezolizumab showed a 50% objective response rate (ORR) in FGF19-positive individuals with HCC.
Abbisko was founded in April 2016 and is based in China.
In 2023, Abbisko from a聽Phase Ib trial of Pimicotinib (ABSK021) for treating advanced tenosynovial giant cell tumour (TGCT).
