FDA accelerates approval of innovative FGFR inhibitors Liantuo Biotech owns development rights in China

On May 28, 2021, BridgeBio Pharma through its subsidiary company QED Therapeutics and Helsinn Group announced that the US FDA has accelerated the approval of Truseltiq (infigratinib) for the treatment of locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement (CCA) Treated patients.

Cholangiocarcinoma is a type of liver and bile duct cancer, a serious and usually fatal disease that affects approximately 20,000 people in the United States and the European Union each year.

The approval of Truseltiq is based on a phase 2 clinical study involving 108 patients who have previously received at least one advanced CCA treatment.

▲Truseltiq molecular structure (picture source: PubChem)

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Reference materials:

[1] BridgeBio Pharma's Affiliate QED Therapeutics and Partner Helsinn Group Announce FDA Approval of TRUSELTIQTM (infigratinib) for Patients with Cholangiocarcinoma.