FDA Announces Final Withdrawal of the Approval of Truseltiq (infigratinib)
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.
Source: FDA
Posted: May 2024
Related articles
- FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma - May 28, 2021
- BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma - December 1, 2020
Truseltiq (infigratinib) FDA Approval History
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