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The FDA has of infigratinib (Truseltiq) as a second-line treatment for metastatic cholangiocarcinoma at the request of the drugmaker, the agency announced on Friday.

Infigratinib, a fibroblast growth factor receptor (FGFR) inhibitor, had received accelerated approval in 2021 for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma in patients harboring an FGFR2 fusion or other rearrangement based on the drug's overall response rate (23%) and duration of response (5 months) in a phase II study.

"The accelerated approval of infigratinib required the sponsor to conduct postmarketing trials to verify the clinical benefit of the drug," the agency stated, adding that sponsor QED Therapeutics ultimately voluntarily requested the withdrawal of infigratinib's approval.

"The sponsor's request cited difficulties in recruiting and enrolling study subjects for the required 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," the FDA said.

Investigators reported results from the at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. According to data in the abstract, the study screened over 1,000 patients and ultimately randomized 48 participants with advanced cholangiocarcinoma and an FGFR2 gene fusion/rearrangement in a 2:1 ratio to either infigratinib or gemcitabine plus cisplatin, with crossover in the infigratinib arm permitted at progression.

Median progression-free survival reached 7.4 months in the infigratinib arm and 8 months with gemcitabine/cisplatin. Response rates were 37.9% and 15.8%, respectively.

The researchers observed that termination of the trial "highlights the challenge of performing confirmatory studies in biomarker-selected subpopulations of rare tumors and the importance of exploring alternative approaches to delivering confirmatory data for regulatory purposes."

Of note, two other drugs remain approved for intrahepatic cholangiocarcinoma related to FGFR2 gene fusions or rearrangements, pemigatinib (Pemazyre) and futibatinib (Lytgobi), both of which were also approved under the accelerated approval pathway.

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