Abbisko (和誉医药) shared OncoDaily’s post on LinkedIn, adding:
“This designation may accelerate global development and regulatory review, signaling growing momentum for biomarker-driven therapies in liver cancer.”
Quoting OncoDaily’s post:
“FDA Fast Track for Precision Therapy in Advanced HCC
The U.S. FDA has granted Fast Track Designation to irpagratinib (ABSK-011), a highly selective FGFR4 inhibitor developed by Abbisko Therapeutics , for patients with FGF19-overexpressing advanced hepatocellular carcinoma who have progressed after ICIs and mTKIs.
Why this matters
FGF19 overexpression is seen in ~30% of HCC and is associated with poorer outcomes. Targeting the FGF19–FGFR4 pathway represents a true precision-oncology approach in a setting with limited post-immunotherapy options.
Key data highlights
- Phase I monotherapy: ORR 46.7% | mPFS 5.5 months
- Combination with atezolizumab: ORR >50% | mPFS >7 months
- Manageable safety profile
This designation may accelerate global development and regulatory review, signaling growing momentum for biomarker-driven therapies in liver cancer.”
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