Notice2024-28033
Use of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availability
Primary source
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Published
November 29, 2024
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 "Use of Circulating Tumor DNA for Curative-Intent Solid Tumor Drug Development." This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting. This guidance finalizes the draft guidance entitled "Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development" issued on May 2, 2022.
Full Text
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<title>Federal Register, Volume 89 Issue 230 (Friday, November 29, 2024)</title>
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[Federal Register Volume 89, Number 230 (Friday, November 29, 2024)]
[Notices]
[Pages 94738-94740]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28033]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0084]
Use of Circulating Tumor Deoxyribonucleic Acid for Curative-
Intent Solid Tumor Drug Development; 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 ``Use of
Circulating Tumor DNA for Curative-Intent Solid Tumor Drug
Development.'' This guidance is intended to help sponsors planning to
use circulating cell-free plasma derived tumor DNA (ctDNA) as a
biomarker in cancer clinical trials conducted under an investigational
new drug application (IND) and/or to support marketing approval of
drugs and biological products for treating solid tumor malignancies in
the early-stage (curative-intent) setting. This guidance finalizes the
draft guidance entitled ``Use of Circulating Tumor DNA for Early-Stage
Solid Tumor Drug Development'' issued on May 2, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on November 29, 2024.
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 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-2022-D-0084 for ``Use of Circulating
[[Page 94739]]
Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug
Development.'' 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; Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
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: Paz Vellanki, Center for Drug
Evaluation and Research (HFD-150), Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9366; James
Myers, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993, 240-402-7911; or Center for Devices and Radiological
Health, <a href="/cdn-cgi/l/email-protection#0e4d4a5c464d626760676d6f624b78676a6b606d6b4e686a6f2066667d20696178"><span class="__cf_email__" data-cfemail="93d0d7c1dbd0fffafdfaf0f2ffd6e5faf7f6fdf0f6d3f5f7f2bdfbfbe0bdf4fce5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Use of Circulating Tumor DNA for Curative-Intent Solid Tumor
Drug Development.'' This guidance is intended to help sponsors planning
to use circulating cell-free plasma derived tumor DNA (ctDNA) as a
biomarker in cancer clinical trials conducted under an IND and/or to
support marketing approval of drugs and biological products for
treating solid tumor malignancies in the early-stage (curative-intent)
setting.
Certain patients with early-stage solid tumors can be cured with
local therapy alone (e.g., surgery, radiation, or chemoradiation),
other patients require (neo)adjuvant systemic therapy in order to be
cured, and others may progress to metastatic disease despite surgery
and/or systemic therapy. ctDNA is tumor-derived fragmented DNA shed
into a patient's bloodstream that is not associated with cells. ctDNA
quantity can vary among individuals and depends on the type of tumor,
location, stage, tumor burden, and response to therapy. ctDNA as a
biomarker has a number of potential regulatory and clinical uses in the
early-stage setting that may assist and expedite drug development. In
the early-stage cancer setting, ctDNA may be used to detect a certain
targetable alteration, to enrich a high- or low-risk population for
study in a trial, to reflect a patient's response to treatment, or,
potentially, as an early marker of efficacy.
This guidance finalizes the draft guidance entitled, ``Use of
Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development,''
issued on May 2, 2022 (87 FR 26207). FDA considered comments received
on the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include edits to further explain the
rationale for writing a guidance on use of ctDNA for solid tumor drug
development specific to the early-stage, curative-intent disease
setting. The part of the guidance that discusses assay considerations
was also clarified to indicate that while a major focus of this section
pertains to assessment of molecular residual disease (MRD), there may
be other uses of ctDNA in the early-stage disease setting. 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 ``Use of Circulating Tumor DNA for Curative-
Intent Solid Tumor Drug Development.'' 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR parts 50 and 56 have been approved under OMB control number
0910-0130; the collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 601
have been approved under OMB control number 0910-0338; the collections
of information in 21 CFR part 800 have been approved under OMB control
number 0910-0625; and the collections of information pertaining to
submission of a biologics license application under section 351(k) of
the Public Health Service Act (42 U.S.C. 262(k)) have been approved
under OMB control number 0910-0718.
[[Page 94740]]
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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>,
<a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</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 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28033 Filed 11-27-24; 8:45 am]
BILLING CODE 4164-01-P
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