Federal Register / Vol. 87, No. 104 / Tuesday, May 31, 2022 / Notices 32425 

oral presentations should notify the 

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be reasonably accommodated during the 

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person will notify interested persons 

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Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11668 Filed 5–26–22; 11:15 am] 

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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. 

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DATES: Approval is withdrawn as of 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, Kimberly.Lehrfeld@

fda.hhs.gov. 

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 

§ 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 § 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 § 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 § 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] 

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