China’s CDE grants breakthrough
China’s CDE grants breakthrough status approval to Abbisko’s HCC therapy
The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted Breakthrough Therapy Designation approval to Abbisko Therapeutics’ 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’s 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.
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).
