Notice2021-13388
Premenopausal Women With Breast Cancer: Developing Drugs for Treatment; Guidance for Industry; Availability
Primary source
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Published
June 24, 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 final guidance for industry entitled "Premenopausal Women with Breast Cancer: Developing Drugs for Treatment." This guidance provides recommendations regarding the inclusion of premenopausal women in breast cancer clinical trials. The guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials for breast cancer drugs. This guidance finalizes the draft guidance of the same title issued on October 8, 2020.
Full Text
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33313-33315]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13388]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1553]
Premenopausal Women With Breast Cancer: Developing Drugs for
Treatment; 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
``Premenopausal Women with Breast Cancer: Developing Drugs for
Treatment.'' This guidance provides recommendations regarding the
inclusion of premenopausal women in breast cancer clinical trials. The
guidance is intended to assist stakeholders, including sponsors and
institutional review boards, responsible for the development and
oversight of clinical trials for breast cancer drugs. This guidance
finalizes the draft guidance of the same title issued on October 8,
2020.
DATES: The announcement of the guidance is published in the Federal
Register on June 24, 2021.
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
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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-2020-D-1553 for ``Premenopausal Women with Breast Cancer:
Developing Drugs for Treatment.'' 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
(CDER), Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or Office
of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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: Jennifer Gao, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2135, Silver Spring, MD 20993, 240-402-
4683; or Julia Beaver, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100,
Silver Spring, MD 20993, 240-402-0489; or Stephen Ripley, 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Premenopausal Women with Breast Cancer: Developing Drugs for
Treatment.'' This guidance provides recommendations regarding the
inclusion of premenopausal women, as defined by serum hormonal levels
(including but not limited to follicle-stimulating hormone and
estradiol), in breast cancer clinical trials. The issues of fertility
and fertility preservation when treating premenopausal women with
breast cancer are outside the scope of this guidance.
Historically, premenopausal women have been excluded from some
trials that have investigated the efficacy of certain drugs that rely
upon manipulation of the hormonal axis for the treatment of hormone
receptor (HR) positive breast cancer. In some cases, separate studies
have been conducted to confirm the benefit in this patient population.
Certain groups of drugs, such as chemotherapy, immunotherapy, and
targeted therapy (which act independent of the hormonal axis), have
similar efficacy in pre- and postmenopausal women with breast cancer.
Based on a review of the literature, FDA believes hormonal drugs
administered to premenopausal women with HR-positive breast cancer,
with adequate estrogen suppression, are likely to have the same
efficacy and safety profile as in postmenopausal women.
The guidance encourages sponsors to discuss their breast cancer
drug development plan with CDER and CBER, as applicable, early in
development. The guidance recommends that menopausal status should not
be the basis for exclusion from breast cancer clinical trials. The
guidance includes recommendations regarding eligibility criteria and
study planning and design intended to facilitate the inclusion of
premenopausal women in breast cancer clinical trials.
This guidance finalizes the draft guidance entitled ``Premenopausal
Women with Breast Cancer: Developing Drugs for Treatment'' issued on
October 8, 2020 (85 FR 63559). FDA considered comments received on the
draft guidance as the guidance was finalized. Changes from the draft to
the final guidance include additional recommendations on the importance
of clinical studies reflecting racial and ethnic diversity and to
collect patient experience data throughout the development program.
Other changes include updated recommendations on collection of clinical
effects as part of the clinical development program or as part of a
postmarketing requirement or commitment as applicable.
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 ``Premenopausal Women with Breast Cancer:
Developing Drugs for Treatment.'' 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
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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; the collections of information in
21 CFR part 314 have been approved under OMB control number 0910-0001;
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 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/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/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: June 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13388 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P
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