Document ID: FDA-2022-N-0850-0001
Agency: fda
Document Type: Notice
Title: Gilead Sciences, Inc.; Withdrawal of Approval of Indications for Relapsed  and Relapsed Small Lymphocytic Lymphoma for ZYDELIG (Idelalisib) Tablets
Posted Date: 2022-05-26T04:00Z

[Federal Register Volume 87, Number 102 (Thursday, May 26, 2022)]
[Notices]
[Page 32031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11277]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0850]

Gilead Sciences, Inc.; Withdrawal of Approval of Indications for 
Relapsed Follicular Lymphoma and Relapsed Small Lymphocytic Lymphoma 
for ZYDELIG (Idelalisib) Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that it is withdrawing approval of the indications for relapsed 
follicular lymphoma and relapsed small lymphocytic lymphoma for ZYDELIG 
(idelalisib) Tablets, approved under new drug application (NDA) 205858, 
held by Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404 
(Gilead). Gilead voluntarily requested that the Agency withdraw 
approval of these indications and waived its opportunity for a hearing.

DATES: Approval is withdrawn as of May 26, 2022.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 July 23, 2014, FDA approved NDA 205858 
for ZYDELIG (idelalisib) Tablets for the treatment of patients with 
relapsed follicular B-cell non-Hodgkin lymphoma in patients who have 
received at least two prior systemic therapies (the follicular lymphoma 
indication). On that same day, FDA also approved NDA 205858 for ZYDELIG 
(idelalisib) Tablets for the treatment of patients with relapsed small 
lymphocytic lymphoma in patients who have received at least two prior 
systemic therapies (the SLL indication). FDA approved both the 
follicular lymphoma indication and the SLL indication under the 
Agency's accelerated approval regulations, 21 CFR part 314, subpart H. 
As a condition of accelerated approval of ZYDELIG (idelalisib) Tablets 
for the follicular lymphoma indication and the SLL indication, the 
applicant was required to conduct postmarketing trials to verify the 
clinical benefit of idelalisib for the follicular lymphoma and SLL 
indications.
    On November 22, 2021, FDA met with Gilead to discuss the status of 
ZYDELIG (idelalisib) Tablet's accelerated approval for the follicular 
lymphoma indication and the SLL indication, including the continued 
need for postmarketing trials intended to verify clinical benefit in 
follicular lymphoma and small lymphocytic lymphoma. FDA raised 
withdrawal of approval during this discussion, explaining its intent to 
consult the Oncologic Drugs Advisory Committee (ODAC) on whether FDA 
should pursue withdrawal of the follicular lymphoma indication and the 
SLL indication. Subsequently, on December 17, 2021, following further 
communication with Gilead, FDA advised Gilead that voluntary withdrawal 
of approval for these indications would be appropriate under Sec.  
314.150(d) (21 CFR 314.150(d)). On January 10, 2022, Gilead submitted a 
letter requesting withdrawal of the follicular lymphoma indication and 
the SLL indication for ZYDELIG (idelalisib) Tablets and waiving its 
opportunity for a hearing. Gilead subsequently clarified, on February 
23, 2022, that they were requesting the Agency withdraw approval of the 
follicular lymphoma indication and the SLL indication pursuant to Sec.  
314.150(d).
    Therefore, under Sec.  314.150(d), approvals of the follicular 
lymphoma indication and the SLL indication for ZYDELIG (idelalisib) 
Tablets are withdrawn as of May 26, 2022. Withdrawal of approval of 
these indications does not affect any other approved indication for 
ZYDELIG (idelalisib) Tablets.

    Dated: May 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11277 Filed 5-25-22; 8:45 am]
BILLING CODE 4164-01-P