[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Page 32425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11631]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0887]


TG Therapeutics, Inc.; Withdrawal of Approval of New Drug 
Application for UKONIQ (Umbralisib Tosylate) Tablets, Equivalent to 200 
Milligrams Base

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 UKONIQ 
(umbralisib tosylate) Tablets, equivalent to (EQ) 200 milligrams (mg) 
Base, held by TG Therapeutics, Inc., 3020 Carrington Mill Blvd., 
Morrisville, NC 27560. TG Therapeutics, Inc. (TGT) 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DATES: Approval is withdrawn as of May 31, 2022.

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 February 5, 2021, FDA approved NDA 213176 
for UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, for the 
treatment of adult patients with: (1) Relapsed or refractory marginal 
zone lymphoma (MZL) who have received at least one prior anti-CD20-
based regimen and (2) relapsed or refractory follicular lymphoma (FL) 
who have received at least three prior lines of systemic therapy, under 
the Agency's accelerated approval regulations, 21 CFR part 314, subpart 
H. The accelerated approval of UKONIQ (umbralisib tosylate) Tablets, EQ 
200 mg base, for MZL and FL included required postmarketing trials 
intended to verify the clinical benefit of UKONIQ.
    On February 3, 2022, FDA issued a Drug Safety Communication about a 
possible increased risk of death with UKONIQ (umbralisib tosylate) 
Tablets, EQ 200 mg base. FDA's initial review of data from a phase 3, 
randomized, controlled clinical trial in patients with chronic 
lymphocytic leukemia (CLL) who were administered UKONIQ (umbralisib 
tosylate) Tablets, EQ 200 mg base, in combination with a monoclonal 
antibody drug compared to the control arm showed a possible increased 
risk of death in patients receiving the combination of UKONIQ 
(umbralisib tosylate) Tablets, EQ 200 mg base, and the monoclonal 
antibody (UNITY-CLL trial). Those patients receiving the combination 
also experienced more serious adverse events than those in the control 
arm. FDA considered the data from the UNITY-CLL trial conducted in 
patients with CLL to have implications for UKONIQ's approved uses for 
MZL and FL.
    On March 10, 2022 (87 FR 13736), FDA published the Federal Register 
notice ``Oncologic Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments,'' announcing 
that UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, would be 
discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting 
scheduled for April 22, 2022.
    FDA met with TGT on April 14, 2022, to discuss voluntary withdrawal 
of UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, pursuant to 
Sec.  314.150(d) (21 CFR 314.150(d)) due to the decrement in overall 
survival and increased serious adverse events observed with UKONIQ 
(umbralisib tosylate) Tablets, EQ 200 mg base, in the UNITY-CLL trial. 
FDA recommended the applicant voluntarily request withdrawal of 
approval of UKONIQ (umbralisib tosylate) Tablets, EQ 200 mg base, for 
the follicular lymphoma and marginal zone lymphoma indications pursuant 
to Sec.  314.150(d) and requested TGT waive its opportunity for a 
hearing.
    On April 15, 2022, TGT submitted a letter asking FDA to withdraw 
approval of NDA 213176 for UKONIQ (umbralisib tosylate) Tablets, EQ 200 
mg base, pursuant to Sec.  314.150(d) and waiving its opportunity for a 
hearing. On April 18, 2022, FDA acknowledged TGT's request for 
withdrawal of approval of the NDA and waiver of its opportunity for a 
hearing. FDA also cancelled the ODAC meeting scheduled for April 22, 
2022, because the meeting was unnecessary considering the applicant's 
withdrawal request.
    For the reasons discussed above, and in accordance with the 
applicant's request, approval of NDA 213176 for UKONIQ (umbralisib 
tosylate) Tablets, EQ 200 mg base, and all amendments and supplements 
thereto, is withdrawn under Sec.  314.150(d). Distribution of UKONIQ 
(umbralisib tosylate) Tablets, EQ 200 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: May 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11631 Filed 5-27-22; 8:45 am]
BILLING CODE 4164-01-P


