HUTCHMED has announced that the China National Medical Products Administration has granted priority review to its New Drug Application for fanregratinib that aims at treating aggressive liver cancer.

 

The drug targets adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement who have previously received systemic therapy.

 

Fanregratinib (HMPL-453) is a novel, selective, oral inhibitor targeting FGFR 1/2/3. ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium. 

 

It accounts for 8.2–15% of primary liver cancers, making it the second most common type after hepatocellular carcinoma. Its incidence is rising, and the 5-year overall survival rate is approximately 9%. Globally, 10–15% of ICC patients have tumors with FGFR2 fusions or rearrangements.

 

The NDA is backed by data from a single-arm, multi-center, open-label Phase II study in China, which met its primary endpoint of objective response rate (ORR). 

 

"Results from the secondary endpoints including progression-free survival (PFS), disease control rate (DCR), duration of response (DoR) and overall survival (OS) also support the primary endpoint findings," HUTCHMED stated.