FDA Withdraws Infigratinib Approval for Cholangiocarcinoma
The FDA has withdrawn the approval for infigratinib to treat patients with cholangiocarcinoma. A phase 3 study comparing it to standard treatment has also been halted. The FDA approval for infigratinib (Truseltiq) to treat cholangiocarcinoma has been withdrawn.
The sponsor had trouble finding enough patients for a required confirmatory study and decided it was not commercially viable to keep selling the drug for this use. The planned phase 3 trial to see if infigratinib was better than standard treatment was discontinued.
The approval of infigratinib for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement has been withdrawn by the FDA.
The sponsor of the agent, QED Therapeutics, cited difficulties enrolling patients to the required confirmatory study following infigratinib’s accelerated approval in May 2021 for the treatment of patients with cholangiocarcinoma who harbor an FGFR2 gene fusion or rearrangement.
In addition to determining the continued distribution of infigratinib for the second-line treatment of cholangiocarcinoma to be not commercially reasonable, the sponsor voluntarily requested the withdrawal of infigratinib.
Bile duct cancer is a rare disease in which malignant (cancer) cells form in the bile ducts. Bile duct cancer is also called cholangiocarcinoma.
The multicenter, open-label, controlled study randomized patients in a 2:1 fashion to receive infigratinib or gemcitabine plus cisplatin. While not closed for safety reasons, the study has been terminated. The sponsor decided to close the study due to the discontinuation of infigratinib development in oncology within the sponsor's territory.
May 22, 2024
