Notice2024-18970
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
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Published
August 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 164 (Friday, August 23, 2024)</title>
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[Federal Register Volume 89, Number 164 (Friday, August 23, 2024)]
[Notices]
[Pages 68164-68166]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18970]
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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.
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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:
<a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<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
[[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 <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-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
<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.'' 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 <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 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: <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.
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: <a href="/cdn-cgi/l/email-protection#470803060407212326692f2f3469202831"><span class="__cf_email__" data-cfemail="9bd4dfdad8dbfdfffab5f3f3e8b5fcf4ed">[email protected]</span></a>, 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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:
<bullet> adequacy of PD-L1 expression as a predictive biomarker for
patient selection in this patient population;
<bullet> differing risk-benefit assessments in different
subpopulations defined by PD-L1 expression; and
<bullet> 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:
<bullet> sBLA 125554/S-091 for OPDIVO (nivolumab) injection,
submitted by Bristol Myers-Squibb Co.; and
<bullet> 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:
<bullet> adequacy of PD-L1 expression as a predictive biomarker for
patient selection in this patient population;
<bullet> differing risk-benefit assessments in different
subpopulations defined by PD-L1 expression; and
<bullet> 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:
<bullet> sBLA 125514/S-096 for KEYTRUDA (pembrolizumab) injection,
submitted by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co.,
Inc.;
<bullet> sBLAs 125554/S-105 and S-106 for OPDIVO (nivolumab)
injection, submitted by Bristol Myers-Squibb Co.; and
<bullet> 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
<a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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
<a href="/cdn-cgi/l/email-protection#aacccecbc5c7cbeacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="dcbab8bdb3b1bd9cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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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