[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]


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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: 
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

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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