2024-10714. 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.

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Approval is withdrawn as of May 16, 2024.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, [e-mail].

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 § 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 § 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 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 § 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.