[Federal Register Volume 89, Number 96 (Thursday, May 16, 2024)]
[Notices]
[Pages 42887-42888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2178]


Helsinn Healthcare SA; Withdrawal of Approval of New Drug 
Application for TRUSELTIQ (Infigratinib Phosphate) Capsules, 25 
Milligrams and 100 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of the new drug application (NDA) for TRUSELTIQ 
(infigratinib phosphate) Capsules, 25 milligrams (mg) and 100 mg, held 
by Helsinn Healthcare SA, C/O Helsinn Therapeutics (U.S.), Inc. 
(Helsinn), 200 Wood Ave. South, Suite 100, Iselin, NJ 08830. Helsinn 
has voluntarily requested that FDA withdraw approval of this 
application and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of May 16, 2024.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].

SUPPLEMENTARY INFORMATION: On May 28, 2021, FDA approved NDA 214622 for 
TRUSELTIQ (infigratinib phosphate) Capsules, 25 mg and 100 mg, for the 
treatment of adults with previously treated, unresectable locally 
advanced or metastatic cholangiocarcinoma (advanced bile duct cancer or 
advanced cholangiocarcinoma) with a fibroblast growth factor receptor 2 
fusion or other rearrangement as detected by an FDA-approved test, 
under the Agency's accelerated approval regulations, 21 CFR part 314, 
subpart H. The accelerated approval of TRUSELTIQ (infigratinib 
phosphate) Capsules, 25 mg and 100 mg, for advanced bile duct cancer or 
advanced cholangiocarcinoma included required postmarketing trials 
intended to verify the clinical benefit of TRUSELTIQ.
    On October 5, 2022, Helsinn voluntarily requested withdrawal of 
approval of TRUSELTIQ (infigratinib phosphate) Capsules, 25 mg and 100 
mg. On February 15, 2023, FDA recommended that the applicant submit a 
letter to voluntarily request withdrawal of approval of TRUSELTIQ 
(infigratinib phosphate) Capsules, 25 mg and 100 mg, according to Sec.  
314.150(d) (21 CFR 314.150(d)) due to the company's inability to 
conduct a clinical trial to verify clinical benefit. On April 21, 2023, 
FDA requested Helsinn waive its opportunity for a hearing.
    On May 30, 2023, Helsinn submitted a letter asking FDA to withdraw 
approval of NDA 214622 for TRUSELTIQ (infigratinib phosphate) Capsules, 
25 mg and 100 mg, according to Sec.  314.150(d) and waiving its 
opportunity for a hearing. In its letter requesting withdrawal of 
approval, Helsinn stated that it is voluntarily requesting withdrawal 
due to difficulties in recruiting and enrolling study subjects for the 
required confirmatory clinical trial 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) is 
not commercially reasonable. Helsinn stated

[[Page 42888]]

that it agreed to withdrawal of the application for this reason only.
    For the reasons discussed above, and in accordance with the 
applicant's request, approval of NDA 214622 for TRUSELTIQ (infigratinib 
phosphate) Capsules, 25 mg and 100 mg, and all amendments and 
supplements thereto, is withdrawn under Sec.  314.150(d). Distribution 
of TRUSELTIQ (infigratinib phosphate) Capsules, 25 mg and 100 mg, into 
interstate commerce without an approved application is illegal and 
subject to regulatory action (see sections 505(a) and 301(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d))).

    Dated: May 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10714 Filed 5-15-24; 8:45 am]
BILLING CODE 4164-01-P