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Truseltiq FDA Approval History

Last updated by Judith Stewart, BPharm on June 2, 2021.

FDA Approved: Yes (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 is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Development Timeline for Truseltiq

DateArticle
May 28, 2021Approval  FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma
Dec  1, 2020BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma

Further information

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