Notice2022-26464
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; Guidance for Industry; Availability
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Published
December 6, 2022
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 final 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 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 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 other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products. This guidance finalizes the draft guidance of the same title issued on August 26, 2021.
Full Text
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<title>Federal Register, Volume 87 Issue 233 (Tuesday, December 6, 2022)</title>
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[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Notices]
[Pages 74635-74637]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26464]
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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;
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 final 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 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 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 other drugs
or biologics, changes in route of administration, or novel formulations
of previously approved PD-1/PD-L1 products. This guidance finalizes the
draft guidance of the same title issued on August 26, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on December 6, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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
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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 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 this 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
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Brian Booth, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 51, Silver Spring, MD 20993, 301-796-1508.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a 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 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 guidance is based on accumulated
scientific and regulatory experience for PD-1 and PD-L1 drugs, 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 the original clinical
efficacy and safety trials that served as the basis of approval of the
current dosing regimen, or in the pre-approval setting, dosing regimens
that differ from those tested in earlier PK and efficacy studies
conducted during development. These alternative IV dosing regimens are
typically designed to change doses and dosing intervals. Longer dosing
intervals 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 guidance describes the
criteria for using the PK-based approach and the documents that should
be included in the submissions seeking approval.
This guidance finalizes the draft guidance of the same title issued
on August 26, 2021 (86 FR 47649). FDA considered comments received on
the draft guidance as it finalized the guidance. Changes from the draft
to the final guidance include: (1) PK-based approach to support
approval of alternative dosing regimens for PD-1/PD-L1 blocking
antibody products may apply to pre- and post-approval setting and (2)
this approach may apply to PD-1/PD-L1 monotherapies and combination
regimens where the dose and/or dose schedule of the PD-1/PD-L1 is the
only proposed change. In addition, editorial changes were made to
improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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 another 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
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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 OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<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: November 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26464 Filed 12-5-22; 8:45 am]
BILLING CODE 4164-01-P
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