Notice2021-18317
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-Ligand 1 Blocking Antibodies for Treatment of Patients With Cancer; Draft Guidance for Industry; Availability
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Published
August 26, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer." This draft guidance provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. This draft guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, and as such, does not address development of alternative dosing regimens for any other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products.
Full Text
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<title>Federal Register, Volume 86 Issue 163 (Thursday, August 26, 2021)</title>
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[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47649-47650]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18317]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0691]
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing
Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-
Ligand 1 Blocking Antibodies for Treatment of Patients With Cancer;
Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Pharmacokinetic-Based Criteria for Supporting Alternative Dosing
Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell
Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients
with Cancer.'' This draft guidance provides recommendations for
sponsors of investigational new drug applications (INDs) and biologics
license applications (BLAs) on the use of pharmacokinetic (PK)-based
criteria to support the approval of alternative dosing regimens for
programmed cell death receptor-1 (PD-1) or programmed cell death-ligand
1 (PD-L1) blocking antibodies. This draft guidance is based on
accumulated scientific and regulatory experience for PD-1 and PD-L1
drugs, and as such, does not address development of alternative dosing
regimens for any other drugs or biologics, changes in route of
administration, or novel formulations of previously approved PD-1/PD-L1
products.
DATES: Submit either electronic or written comments on the draft
guidance by October 25, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-D-0691 for ``Pharmacokinetic-Based Criteria for Supporting
Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1)
or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for
Treatment of Patients with Cancer.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential
[[Page 47650]]
with a heading or cover note that states ``THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Brian Booth, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2186, Silver Spring, MD 20993, 301-796-
1508.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Pharmacokinetic-Based Criteria for Supporting Alternative
Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or
Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for
Treatment of Patients with Cancer.'' This draft guidance provides
recommendations for sponsors of INDs and BLAs on the use of PK-based
criteria to support the approval of alternative dosing regimens for PD-
1 or PD-L1 blocking antibodies. The draft guidance is based on
accumulated scientific and regulatory experience for PD-1 and PD-L1
drugs and, as such, does not address development of alternative dosing
regimens for any other drugs or biologics, changes in route of
administration, or novel formulations of previously approved PD-1/PD-L1
products.
Sponsors may seek approval of alternative intravenous (IV) dosing
regimens that are different from those tested in clinical efficacy and
safety trials. These alternative IV dosing regimens are typically
designed to change doses (e.g., body weight adjusted doses to flat
doses) and/or dosing intervals (e.g., once every 3 weeks to once every
6 weeks). Longer dosing interval periods can minimize patient burden
and reduce risks associated with more frequent administration (e.g.,
infusion reactions), as well as exposure to communicable diseases
(e.g., SARS-CoV-2) associated with visits to hospitals or infusion
centers. The draft guidance describes the criteria for using the PK-
based approach and the documents that should be included in the
submissions seeking approval.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Pharmacokinetic-Based Criteria for Supporting Alternative Dosing
Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell
Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients
with Cancer.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014 and the collections of information in 21 CFR part 601
have been approved under 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18317 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P
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