Truseltiq FDA Approval History
Last updated by Judith Stewart, BPharm on May 21, 2024.
FDA Approved: Yes (Discontinued) (First approved May 28, 2021)
Brand name: Truseltiq
Generic name: infigratinib
Dosage form: Capsules
Company: BridgeBio Pharma, Inc.
Treatment for: Cholangiocarcinoma
Truseltiq (infigratinib) is an FGFR tyrosine kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- This indication was approved under accelerated approval based on overall response rate and duration of response.
- On May 16, 2024, the FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
- The accelerated approval of infigratinib required the sponsor to conduct postmarketing trials to verify the clinical benefit of the drug.
- The sponsor voluntarily requested withdrawal of infigratinib.
- The sponsor’s request cited difficulties in recruiting and enrolling study subjects for the required confirmatory clinical trial in first line cholangiocarcinoma (a new indication under investigation for Truseltiq), and the determination that, as a result, continued distribution of Truseltiq in second line cholangiocarcinoma (the accelerated approval indication) was not commercially reasonable.
Development timeline for Truseltiq
Further information
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