Document ID: FDA-2022-N-0529-0001
Agency: fda
Document Type: Notice
Title: Secura Bio, Inc.; Withdrawal of Approval of Relapsed or Refractory Follicular Lymphoma Indication for COPIKTRA
Posted Date: 2022-04-13T04:00Z

[Federal Register Volume 87, Number 71 (Wednesday, April 13, 2022)]
[Notices]
[Pages 21888-21889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07931]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0529]

Secura Bio, Inc.; Withdrawal of Approval of Relapsed or 
Refractory Follicular Lymphoma Indication for COPIKTRA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is withdrawing approval of the relapsed or refractory follicular 
lymphoma indication for COPIKTRA (duvelisib) Capsules, approved under 
new drug application 211155, held by Secura Bio, Inc., 1995 Village 
Center Circle, Suite 128, Las Vegas, NV 89134. Secura Bio, Inc. 
voluntarily requested that the Agency withdraw approval of this 
indication and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of April 13, 2022.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: FDA approved COPIKTRA (duvelisib) Capsules 
for the treatment of adult patients with relapsed or refractory 
follicular lymphoma after at least two prior systemic therapies (the 
follicular lymphoma indication) on September 24, 2018, under the 
Agency's accelerated approval regulations, 21 CFR part 314, subpart H. 
As a condition of accelerated approval of COPIKTRA (duvelisib) Capsules 
for follicular lymphoma, the applicant was required to conduct a 
postmarketing trial to verify the clinical benefit of duvelisib for 
follicular lymphoma.
    On November 22, 2021, FDA met with Secura Bio, Inc., to discuss the 
company's inability to conduct a

[[Page 21889]]

clinical trial to verify clinical benefit of duvelisib in follicular 
lymphoma. Because the confirmatory trial was not underway and would not 
be conducted, the Agency recommended withdrawal of approval of the 
follicular lymphoma indication pursuant to Sec.  314.150(d) (21 CFR 
314.150(d)). On November 24, 2021, Secura Bio, Inc. submitted a letter 
requesting withdrawal of approval of the follicular lymphoma indication 
for COPIKTRA (duvelisib) Capsules and waiving its opportunity for 
hearing.
    Therefore, under Sec.  314.150(d), approval of the follicular 
lymphoma indication for COPIKTRA (duvelisib) Capsules is withdrawn 
effective April 13, 2022. Withdrawal of approval of the follicular 
lymphoma indication does not affect any other approved indication for 
COPIKTRA.

    Dated: April 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07931 Filed 4-12-22; 8:45 am]
BILLING CODE 4164-01-P