Events Details
HUTCHMED Announces Approval of ATLED® (Fanregratinib) for FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma
Tuesday, September 01, 2026
HUTCHMED has received conditional approval from China’s National Medical Products Administration (NMPA) for ATLED® (fanregratinib) to treat adults with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion or rearrangement who have previously received systemic therapy.
Fanregratinib, also known as HMPL-453, is an oral, selective inhibitor targeting fibroblast growth factor receptor (FGFR) 1, 2 and 3. The medicine will be marketed in China under the brand name ATLED®.
ATLED® (fanregratinib, HMPL-453) is an oral, selective and potent inhibitor of FGFR1, FGFR2 and FGFR3. The FGFR signalling pathway is involved in tumour growth, angiogenesis and resistance to anti-tumour therapies. Alterations in FGFR genes can contribute to tumour cell proliferation across several types of solid tumours.
The conditional approval is supported by results from the Phase II registration cohort of a pivotal Phase II/IIIb, single-arm, multicentre, open-label clinical trial conducted in China.
The study evaluated ATLED® in patients with previously treated advanced ICC harbouring FGFR2 fusions or rearrangements. Results presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2026 showed that the study met its primary endpoint.
The Independent Review Committee (IRC)-assessed objective response rate (ORR) was 42.5%, with a 95% confidence interval of 30.0% to 53.6%. The results demonstrated clinically meaningful anti-tumour activity in the patient population.
The treatment also showed a rapid response, with a median time to response of 1.4 months. The median duration of response was 6.9 months, while the disease control rate reached 83.9%.
The median progression-free survival (PFS) was 6.9 months, and median overall survival (OS) was 16.6 months.
Intrahepatic cholangiocarcinoma is an aggressive cancer that develops in the bile ducts within the liver. It accounts for around 8.2% to 15% of primary liver cancers and is the second most common primary liver cancer after hepatocellular carcinoma.
The disease has a poor prognosis, with a five-year overall survival rate of approximately 9%. FGFR2 fusions or rearrangements are estimated to occur in around 10% to 15% of patients with ICC worldwide, making targeted treatment options important for this patient population.
ATLED® is designed to target abnormal FGFR signalling, which can contribute to tumour growth and other processes involved in cancer progression.
The NMPA approval marks a further step in the development of fanregratinib and provides a targeted treatment option in China for previously treated patients with advanced ICC carrying specific FGFR2 alterations.
Source: hutch-med.com
