- BridgeBio Pharma Inc BBIO, through its affiliate QED Therapeutics Inc and Helsinn Group, has announced FDA approval for Truseltiq (infigratinib) under the accelerated approval program for cholangiocarcinoma (CCA).
- The approval covers patients with previously treated locally advanced or metastatic CCA harboring an FGFR2 fusion or rearrangement.
- Truseltiq is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR.
- The approval of Truseltiq is based on Phase 2 clinical study in which 108 patients who had undergone at least one prior treatment for advanced CCA received 125 mg of TRUSELTIQ daily for 21 days of 28-day cycles.
- The study's primary endpoint demonstrated a confirmed objective response rate (ORR) of 23%. The study also showed a median duration of response (DOR) of 5.0 months.
- Additional marketing applications for infigratinib are currently under review in Australia and Canada.
- BridgeBio and Helsinn Group will be jointly responsible for commercialization activities in the U.S. It will share U.S. profits and losses on an equal basis under the collaboration and licensing agreement announced in March 2021.
- Helsinn Group will have exclusive commercialization rights on infigratinib outside the U.S., excluding China, Hong Kong, and Macau.
- Price Action: BBIO shares are up 1.35% at $60 in the premarket session on the last check Tuesday.
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