The China National Medical Products Administration (NMPA) has granted conditional approval to ATLED (fanregratinib; HMPL-453) for adults with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring an FGFR2 fusion or rearrangement who have previously received systemic therapy.
HUTCHMED announced the approval on August 28, 2026. Fanregratinib is a novel, selective oral inhibitor targeting FGFR1, FGFR2, and FGFR3, and will be marketed in China under the brand name ATLED.
Phase II Trial Supports Fanregratinib Approval
The conditional approval is supported by results from the registration cohort of NCT04353375, a single-arm, multicenter, open-label Phase II/IIIb study evaluating fanregratinib in patients with previously treated advanced ICC and FGFR2 fusions or rearrangements.
The Phase II study met its primary endpoint, with an Independent Review Committee-assessed objective response rate of 42.5%.
Additional results included:
- Disease control rate: 83.9%
- Median time to response: 1.4 months
- Median duration of response: 6.9 months
- Median progression-free survival: 6.9 months
- Median overall survival: 16.6 months
The findings were presented at the ESMO Gastrointestinal Cancers Congress 2026.
Regarding safety, Grade 3 or higher drug-related adverse events were reported in 48.3% of patients. The most common included elevated liver enzymes and palmar-plantar erythrodysesthesia syndrome. Treatment discontinuation because of drug-related adverse events occurred in 2.2% of patients, with no treatment-related deaths reported.
Targeting FGFR2-Altered Intrahepatic Cholangiocarcinoma
ICC is an aggressive cancer originating in the intrahepatic bile ducts and represents the second most common form of primary liver cancer after hepatocellular carcinoma. Approximately 10% to 15% of patients with ICC globally have tumors harboring FGFR2 fusions or rearrangements, creating an opportunity for molecularly targeted treatment.
Fanregratinib is designed to selectively inhibit FGFR1, FGFR2, and FGFR3 signaling. Abnormal FGFR signaling can contribute to tumor cell proliferation, angiogenesis, and resistance to anticancer therapies. HUTCHMED currently retains worldwide rights to fanregratinib.
Confirmatory Study Underway
Because the NMPA approval is conditional, the Phase IIIb portion of NCT04353375 will serve as the confirmatory study to further evaluate the clinical benefit and safety of fanregratinib in this patient population.
Enrollment in the confirmatory cohort began in January 2026.
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