[Federal Register Volume 89, Number 135 (Monday, July 15, 2024)]
[Notices]
[Pages 57418-57419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15371]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

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DATES: Approval is withdrawn as of July 15, 2024.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, [email protected].

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.

[[Page 57419]]

    On October 19, 2023, FDA met with Takeda to discuss the voluntary 
withdrawal of EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base, 
according to Sec.  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 Sec.  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 Sec.  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 Sec.  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.
[FR Doc. 2024-15371 Filed 7-12-24; 8:45 am]
BILLING CODE 4164-01-P