Posted by Michael Wonder on 18 May 2024
FDA withdraws accelerated approval to infigratinib for metastatic cholangiocarcinoma
16 May 2024 - Today, 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 fusion or other rearrangement.
The accelerated approval of infigratinib required the sponsor to conduct post-marketing trials to verify the clinical benefit of the drug. The sponsor voluntarily requested withdrawal of infigratinib.
