The Center for Drug Evaluation (CDE) website has indicated that Nanjing-based TransThera Sciences (Nanjing), Inc.’s candidate TT-00420 is set to receive breakthrough therapy designation (BTD) for the treatment of unresectable advanced or metastatic cholangiocarcinoma. This designation is for patients whose disease recurs after previous systemic chemotherapy and/or FGFR inhibitor treatment.
TT-00420: An Innovative Multi-Kinase Inhibitor with Orphan Drug Designation
TT-00420, an innovative multi-kinase inhibitor, was awarded orphan drug designation (ODD) in the US in 2019. This molecule is currently in a global Phase I clinical trial for advanced solid tumors, with trial sites in both China and the US, highlighting its potential in addressing rare and difficult-to-treat cancers.
Cholangiocarcinoma Treatment Landscape and the Role of Pemazyre
Cholangiocarcinoma is a rare cancer that forms in the bile ducts and is associated with a poor prognosis. Traditional treatments include surgery and chemotherapy. In China, Innovent’s Pemazyre (pemigatinib) is the only novel drug available to treat adult patients with advanced, metastatic, or inoperable cholangiocarcinoma who have received at least one prior systemic therapy and have been confirmed to have FGFR2 fusion or rearrangement through detection methods.-Fineline Info & Tech
