2024-15371. Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of New Drug Application for EXKIVITY (Mobocertinib Succinate) Capsule, Equivalent to 40 Milligrams Base

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2024-N-3165]

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 EXKIVITY (mobocertinib succinate) capsule, equivalent to (EQ) 40 milligrams (mg) base, held by Takeda Pharmaceuticals U.S.A., Inc., 95 Hayden Ave., Lexington, MA 02421 (Takeda). Takeda has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.

DATES:

Approval is withdrawn as of July 15, 2024.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 September 15, 2021, FDA approved NDA 215310 for EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (EGFR exon 20 insertion-mutated NSCLC), under the Agency's accelerated approval regulations, 21 CFR part 314, subpart H. The accelerated approval of EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, for EGFR exon 20 insertion-mutated NSCLC included a required postmarketing trial intended to verify the clinical benefit of EXKIVITY.

On October 19, 2023, FDA met with Takeda to discuss the voluntary withdrawal of EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, according to § 314.150(d) (21 CFR 314.150(d)). On October 25, 2023, FDA recommended the applicant voluntarily request withdrawal of approval of EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, for EGFR exon 20 insertion-mutated NSCLC according to § 314.150(d) because the postmarketing trial did not verify clinical benefit. FDA also requested Takeda waive its opportunity for a hearing.

On March 15, 2024, Takeda submitted a letter asking FDA to withdraw approval of NDA 215310 for EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, according to § 314.150(d) and waiving its opportunity for a hearing.

For the reasons discussed above, and in accordance with the applicant's request, approval of NDA 215310 for EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, and all amendments and supplements thereto, is withdrawn under § 314.150(d). Distribution of EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, 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: July 9, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.