Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma and Esophageal Squamous Cell Carcinoma, 68164-68166 [2024-18970]
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68164
Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Notices
TABLE 2—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued
Active ingredient(s)
Phentermine hydrochloride; Topiramate.
Posaconazole.
Pramipexole dihydrochloride.
Progesterone.
Promethazine hydrochloride.
Quetiapine fumarate.
Tacrolimus.
Tapentadol hydrochloride.
Tiotropium bromide.
Tramadol hydrochloride.
Trospium chloride.
Venlafaxine hydrochloride.
Verteporfin.
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on, among other things,
the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
IV. Paperwork Reduction Act of 1995
While these guidances contain no
collection of information, they do 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
(44 U.S.C. 3501–3521). The collections
of information in 21 CFR part 312 for
investigational new drugs have been
approved under 0910–0014. The
collections of information in 21 CFR
part 314 for applications for FDA
approval to market a new drug and in
21 CFR part 320 for bioavailability and
bioequivalence requirements have been
approved under OMB control number
0910–0001.
khammond on DSKJM1Z7X2PROD with NOTICES
V. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
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Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–18997 Filed 8–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3647]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for
Comments—Immune Checkpoint
Inhibitors in Patients With
Unresectable or Metastatic Gastric and
Gastroesophageal Junction
Adenocarcinoma and Esophageal
Squamous Cell Carcinoma
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Oncologic Drugs
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on
September 26, 2024, from 8 a.m. to 6:15
p.m. Eastern Time.
ADDRESSES: The public may attend the
meeting at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
The public will also have the option to
participate, and the advisory committee
meeting will be heard, viewed,
captioned, and recorded through an
SUMMARY:
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online teleconferencing and/or video
conferencing platform.
Answers to commonly asked
questions about FDA advisory
committee meetings, including
information regarding special
accommodations due to a disability,
visitor parking, and transportation, may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–3647.
The docket will close on September 25,
2024. Please note that late, untimely
filed comments will not be considered.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 25, 2024.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
September 12, 2024, will be provided to
the Committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
E:\FR\FM\23AUN1.SGM
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Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Notices
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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 https://www.regulations.gov.
• 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:
• 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.
• 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–
2024–N–3647 for ‘‘Oncologic Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments—Immune
Checkpoint Inhibitors in Patients with
Unresectable or Metastatic Gastric and
Gastroesophageal Junction
Adenocarcinoma and Esophageal
Squamous Cell Carcinoma.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
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17:23 Aug 22, 2024
Jkt 262001
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information 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 the 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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.
FOR FURTHER INFORMATION CONTACT:
Joyce Frimpong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–7973, email: ODAC@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: During the morning session,
the Committee will discuss the use of
immune checkpoint inhibitors in
patients with unresectable or metastatic
gastric and gastroesophageal junction
adenocarcinoma. The current labeling
for approved checkpoint inhibitors in
this indication reflects broad approvals
in the intent to treat patient populations
agnostic of programmed death cell
ligand-1 (PD-L1) expression. Cumulative
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68165
data have shown that PD-L1 expression
appears to be a predictive biomarker of
treatment efficacy in this patient
population; however, clinical trials have
used different approaches to assess PDL1 expression and different thresholds
to define PD-L1 positivity. FDA would
like the Committee’s opinion on the
following:
• adequacy of PD-L1 expression as a
predictive biomarker for patient
selection in this patient population;
• differing risk-benefit assessments in
different subpopulations defined by PDL1 expression; and
• adequacy of the cumulative data to
restrict the approvals of immune
checkpoint inhibitors based on PD-L1
expression.
The Committee will discuss the
existing supplemental biologics license
applications (sBLA) which were
approved for patients with previously
untreated HER2-negative unresectable
or metastatic gastric or gastroesophageal
adenocarcinoma:
• sBLA 125554/S–091 for OPDIVO
(nivolumab) injection, submitted by
Bristol Myers-Squibb Co.; and
• sBLA 125514/S–143 for
KEYTRUDA (pembrolizumab) injection,
submitted by Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc.
The Committee will also discuss BLA
761417 for tislelizumab injection,
submitted by BeiGene USA, Inc., for the
same proposed indication.
During the afternoon session, the
Committee will discuss the use of
immune checkpoint inhibitors in
patients with metastatic or unresectable
esophageal squamous cell carcinoma.
The current labeling for approved
checkpoint inhibitors in this indication
reflects broad approvals in the intent to
treat patient populations agnostic of PDL1 expression. Cumulative data has
shown that PD-L1 expression appears to
be a predictive biomarker of treatment
efficacy in this patient population;
however, clinical trials have used
different approaches to assess PD-L1
expression and different thresholds to
define PD-L1 positivity. FDA would like
the Committee’s opinion on the
following:
• adequacy of PD-L1 expression as a
predictive biomarker for patient
selection in this patient population;
• differing risk-benefit assessments in
different subpopulations defined by PDL1 expression; and
• adequacy of the cumulative data to
restrict the approvals of immune
checkpoint inhibitors based on PD-L1
expression.
The Committee will discuss the
existing sBLAs which were approved for
patients with previously untreated
E:\FR\FM\23AUN1.SGM
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Federal Register / Vol. 89, No. 164 / Friday, August 23, 2024 / Notices
unresectable or metastatic esophageal
squamous cell carcinoma:
• sBLA 125514/S–096 for
KEYTRUDA (pembrolizumab) injection,
submitted by Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc.;
• sBLAs 125554/S–105 and S–106 for
OPDIVO (nivolumab) injection,
submitted by Bristol Myers-Squibb Co.;
and
• sBLA 125377/S–122 for YERVOY
(ipilimumab) injection, submitted by
Bristol Myers-Squibb Co.
The Committee will also discuss the
new BLA 761380 for tislelizumab,
submitted by BeiGene USA, Inc., for the
same proposed indication.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at the location
of the advisory committee meeting and
at https://www.fda.gov/Advisory
Committees/Calendar/default.htm.
Scroll down to the appropriate advisory
committee meeting link. The meeting
presentations will also be heard,
viewed, captioned, and recorded
through an online teleconferencing and/
or video conferencing platform. The
online presentation of materials will
include slide presentations with audio
and video components in a manner that
most closely resembles an in-person
advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the Committee. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before September 12,
2024, will be provided to the
Committee. Oral presentations from the
public will be scheduled between
approximately 11:15 a.m. to 11:45 a.m.
and 4:45 p.m. to 5:15 p.m. Eastern Time.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, whether they
would like to present online or inperson, and an indication of the
approximate time requested to make
their presentation on or before
September 4, 2024. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
VerDate Sep<11>2014
17:23 Aug 22, 2024
Jkt 262001
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. Similarly, room for
interested persons to participate inperson may be limited. If the number of
registrants requesting to speak in-person
during the open public hearing is
greater than can be reasonably
accommodated in the venue for the inperson portion of the advisory
committee meeting, FDA may conduct a
lottery to determine the speakers who
will be invited to participate in-person.
The contact person will notify
interested persons regarding their
request to speak by September 5, 2024.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Joyce
Frimpong (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform in conjunction with
the physical meeting room (see
location). This waiver is in the interest
of allowing greater transparency and
opportunities for public participation,
in addition to convenience for advisory
committee members, speakers, and
guest speakers. The conditions for
issuance of a waiver under 21 CFR 10.19
are met.
Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–18970 Filed 8–22–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–3788]
Electronic Submission Template for
Medical Device De Novo Requests;
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Electronic
Submission Template for Medical
Device De Novo Requests.’’ FDA is
issuing this guidance to introduce
submitters of De Novo requests to the
Center for Devices and Radiological
Health (CDRH) and Center for Biologics
Evaluation and Research (CBER) to the
current resources and associated content
developed and made publicly available
to support De Novo electronic
submissions to FDA. This guidance is
intended to represent one of several
steps in meeting FDA’s commitment to
the development of electronic
submission templates to serve as guided
submission preparation tools for
industry to improve submission
consistency and enhance efficiency in
the review process.
DATES: The announcement of the
guidance is published in the Federal
Register on August 23, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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
E:\FR\FM\23AUN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 164 (Friday, August 23, 2024)]
[Notices]
[Pages 68164-68166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3647]
Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments--Immune
Checkpoint Inhibitors in Patients With Unresectable or Metastatic
Gastric and Gastroesophageal Junction Adenocarcinoma and Esophageal
Squamous Cell Carcinoma
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee (the Committee). The general function of the Committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on September 26, 2024, from 8 a.m. to
6:15 p.m. Eastern Time.
ADDRESSES: The public may attend the meeting at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503), Silver Spring, MD 20993-0002. The public will also
have the option to participate, and the advisory committee meeting will
be heard, viewed, captioned, and recorded through an online
teleconferencing and/or video conferencing platform.
Answers to commonly asked questions about FDA advisory committee
meetings, including information regarding special accommodations due to
a disability, visitor parking, and transportation, may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2024-N-3647. The docket will close on
September 25, 2024. Please note that late, untimely filed comments will
not be considered. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
September 25, 2024. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
received on or before that date.
Comments received on or before September 12, 2024, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your
[[Page 68165]]
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 https://www.regulations.gov.
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:
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.
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-2024-N-3647 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments--Immune
Checkpoint Inhibitors in Patients with Unresectable or Metastatic
Gastric and Gastroesophageal Junction Adenocarcinoma and Esophageal
Squamous Cell Carcinoma.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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.'' FDA 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 https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information 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 the 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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.
FOR FURTHER INFORMATION CONTACT: Joyce Frimpong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7973, email: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: During the morning session, the Committee will discuss the
use of immune checkpoint inhibitors in patients with unresectable or
metastatic gastric and gastroesophageal junction adenocarcinoma. The
current labeling for approved checkpoint inhibitors in this indication
reflects broad approvals in the intent to treat patient populations
agnostic of programmed death cell ligand-1 (PD-L1) expression.
Cumulative data have shown that PD-L1 expression appears to be a
predictive biomarker of treatment efficacy in this patient population;
however, clinical trials have used different approaches to assess PD-L1
expression and different thresholds to define PD-L1 positivity. FDA
would like the Committee's opinion on the following:
adequacy of PD-L1 expression as a predictive biomarker for
patient selection in this patient population;
differing risk-benefit assessments in different
subpopulations defined by PD-L1 expression; and
adequacy of the cumulative data to restrict the approvals
of immune checkpoint inhibitors based on PD-L1 expression.
The Committee will discuss the existing supplemental biologics
license applications (sBLA) which were approved for patients with
previously untreated HER2-negative unresectable or metastatic gastric
or gastroesophageal adenocarcinoma:
sBLA 125554/S-091 for OPDIVO (nivolumab) injection,
submitted by Bristol Myers-Squibb Co.; and
sBLA 125514/S-143 for KEYTRUDA (pembrolizumab) injection,
submitted by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
The Committee will also discuss BLA 761417 for tislelizumab
injection, submitted by BeiGene USA, Inc., for the same proposed
indication.
During the afternoon session, the Committee will discuss the use of
immune checkpoint inhibitors in patients with metastatic or
unresectable esophageal squamous cell carcinoma. The current labeling
for approved checkpoint inhibitors in this indication reflects broad
approvals in the intent to treat patient populations agnostic of PD-L1
expression. Cumulative data has shown that PD-L1 expression appears to
be a predictive biomarker of treatment efficacy in this patient
population; however, clinical trials have used different approaches to
assess PD-L1 expression and different thresholds to define PD-L1
positivity. FDA would like the Committee's opinion on the following:
adequacy of PD-L1 expression as a predictive biomarker for
patient selection in this patient population;
differing risk-benefit assessments in different
subpopulations defined by PD-L1 expression; and
adequacy of the cumulative data to restrict the approvals
of immune checkpoint inhibitors based on PD-L1 expression.
The Committee will discuss the existing sBLAs which were approved
for patients with previously untreated
[[Page 68166]]
unresectable or metastatic esophageal squamous cell carcinoma:
sBLA 125514/S-096 for KEYTRUDA (pembrolizumab) injection,
submitted by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co.,
Inc.;
sBLAs 125554/S-105 and S-106 for OPDIVO (nivolumab)
injection, submitted by Bristol Myers-Squibb Co.; and
sBLA 125377/S-122 for YERVOY (ipilimumab) injection,
submitted by Bristol Myers-Squibb Co.
The Committee will also discuss the new BLA 761380 for
tislelizumab, submitted by BeiGene USA, Inc., for the same proposed
indication.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at the location of the advisory committee meeting and at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
presentations will also be heard, viewed, captioned, and recorded
through an online teleconferencing and/or video conferencing platform.
The online presentation of materials will include slide presentations
with audio and video components in a manner that most closely resembles
an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before September 12, 2024, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
11:15 a.m. to 11:45 a.m. and 4:45 p.m. to 5:15 p.m. Eastern Time. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, whether they would like to present
online or in-person, and an indication of the approximate time
requested to make their presentation on or before September 4, 2024.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. Similarly, room for interested persons to
participate in-person may be limited. If the number of registrants
requesting to speak in-person during the open public hearing is greater
than can be reasonably accommodated in the venue for the in-person
portion of the advisory committee meeting, FDA may conduct a lottery to
determine the speakers who will be invited to participate in-person.
The contact person will notify interested persons regarding their
request to speak by September 5, 2024. Persons attending FDA's advisory
committee meetings are advised that FDA is not responsible for
providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Joyce Frimpong (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform in conjunction with the physical
meeting room (see location). This waiver is in the interest of allowing
greater transparency and opportunities for public participation, in
addition to convenience for advisory committee members, speakers, and
guest speakers. The conditions for issuance of a waiver under 21 CFR
10.19 are met.
Dated: August 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18970 Filed 8-22-24; 8:45 am]
BILLING CODE 4164-01-P
