Oncology News Central (ONC)FDA Withdraws Approval of Infigratinib for Cholangiocarcinoma

Challenges in Patient Recruitment Lead to Commercial Viability Issues

The US Food and Drug Administration (FDA) has officially withdrawn the approval of infigratinib (Truseltiq) for treating previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangements. This decision follows the sponsor, Helsinn Healthcare SA’s, request due to difficulties in patient recruitment for a confirmatory clinical trial necessary for continued approval. The withdrawal marks the end of infigratinib’s only approved indication in the treatment of cholangiocarcinoma.

Key Points:

• Initial Approval: Infigratinib received accelerated approval from the FDA on May 28, 2021, for use in previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangements.
• Postmarketing Trials Requirement: Continued approval was contingent on the completion of postmarketing trials to confirm clinical benefit.
• Withdrawal Request: Helsinn Healthcare SA requested the withdrawal due to challenges in recruiting patients for a confirmatory trial aimed at evaluating infigratinib as a first-line treatment for advanced cholangiocarcinoma.
• Commercial Viability: Helsinn stated that the continued distribution of infigratinib for second-line therapy was not commercially viable given the difficulties in patient recruitment.
• FDA Announcement: The FDA announced the final withdrawal in a press release and published the information in the Federal Register.
• Timeline: Helsinn first submitted a letter of request for the withdrawal to the FDA on May 30, 2023, nearly a year before the final decision.
• Implications for Physicians: Physicians should be aware that infigratinib is no longer an approved treatment option for cholangiocarcinoma, necessitating consideration of alternative therapies for patients with FGFR2 fusion or rearrangement.

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