BridgeBio, through its affiliate QED and partner Helsinn, intends to co-commercialise the cholangiocarcinoma drug in the US
BridgeBio gets FDA approval for Truseltiq. (Credit: Steve Buissinne from Pixabay.)
BridgeBio Pharma, through its affiliate QED Therapeutics, and partner Helsinn, has received the US Food and Drug Administration (FDA) approval for Truseltiq (infigratinib) to treat a type of cholangiocarcinoma.
Truseltiq is indicated for the treatment of patients with previously-treated locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or rearrangement.
The US FDA has approved the drug under an accelerated approval programme.
Truseltiq is an orally administered, ATP-competitive, tyrosine kinase inhibitor (TKI) that targets the fibroblast growth factor receptor (FGFR) protein, blocking downstream activity.
The FDA approval is based on a Phase 2 clinical study of Truseltiq in 108 patients who had undergone at least one prior treatment for advanced CCA.
The treatment using 125mg of Truseltiq for 21 days showed a confirmed objective response rate (ORR) of 23%, the primary endpoint of the clinical trial.
BridgeBio said that additional marketing applications for the drug are currently underway in Australia and Canada under Project Orbis.
Project Orbis is an FDA initiative that allows for simultaneous submission and review of oncology drugs among participating international regulatory agencies.
BridgeBio and Helsinn Therapeutics, a US affiliate of Helsinn Group, intend to co-commercialise Truseltiq in the US, by equally sharing the profits and losses.
Helsinn will fund most of the ongoing and future oncology research and development and holds exclusive commercialisation rights on the drug outside the US, except in China, Hong Kong and Macau.
BridgeBio is entitled to receive tiered royalties from the net sales, and payments totalling up to an average of nearly $2.45bn.
The company has signed a global collaboration and licensing agreement with Helsinn in March 2021 and has previously collaborated with LianBio for development and commercialisation in China, Hong Kong and Macau.
Helsinn Therapeutics CEO Paul Rittman said: “Today’s FDA approval of TRUSELTIQ for patients with previously-treated locally advanced or metastatic CCA harbouring an FGFR2 fusion or rearrangement provides a new therapy option for patients with a very low rate of survival.
“This new therapy has the potential to make a life-changing impact on patients with few treatment options, and Helsinn Therapeutics looks forward to working with BridgeBio to make it widely accessible to health care providers and patients in the US.”