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FDA Grants Withdrawal of Infigratinib for Cholangiocarcinoma
The US Food and Drug Administration (FDA) has announced the withdrawal of its 2021 accelerated approval of infigratinib (Truseltiq) for patients with a certain type of previously treated cholangiocarcinoma.
Infigratinib initially received accelerated approval in May 2021 for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma and a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
That approval — the first and only for the agent — was contingent on the manufacturer, QED Therapeutics, Inc., verifying the drug's clinical benefit in confirmatory trials.
The approval was withdrawn voluntarily at the request of the sponsor because of "difficulties in recruiting and enrolling study subjects for the required confirmatory clinical trial," according to an FDA update.
The confirmatory clinical trial was exploring the drug's efficacy in the first-line setting — a new indication under investigation. Given the challenges with recruitment and enrolment, the company determined that continued distribution of the agent for the second-line treatment of cholangiocarcinoma — the accelerated approval indication — "was not commercially reasonable," according to the FDA's announcement.
However, studies of the agent for other FGFR-driven conditions are ongoing, according to QED.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on Twitter: @SW_MedReporter.
