4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2559]
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments--Supplemental Biologics License Application 761069/S-043
for IMFINZI (durvalumab) Injection
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 July 25, 2024, from 9 a.m. to 2:15 p.m. Eastern Time.
ADDRESSES: FDA and invited participants may attend the meeting at 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 have the option to participate via an online
teleconferencing and/or video conferencing platform, 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 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-2559. The docket will close on July 24, 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 July 24, 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 July 11, 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 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-2559

for “Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments--Supplemental Biologics License Application 761069/S-043 for
IMFINZI (durvalumab) Injection.” 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: Takyiah Stevenson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31,
Rm. 2417, Silver Spring, MD 20993-0002, 240-402-2507, 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: The meeting presentations will be heard, viewed, captioned, and recorded
through an online teleconferencing and/or video conferencing platform. The Committee will
discuss supplemental biologics license application (sBLA) 761069/S-043, for IMFINZI
(durvalumab) injection, submitted by AstraZeneca UK Limited. The proposed indication (use) is
IMFINZI in combination with chemotherapy as neoadjuvant treatment, followed by IMFINZI as
monotherapy after surgery, for the treatment of adult patients with resectable non-small cell lung
cancer (NSCLC). The Committee will also be asked to discuss whether drug sponsors should be

required to adequately justify treatment of patients both before and after surgery for resectable
NSCLC prior to an approval that would include both neoadjuvant and adjuvant therapy.
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
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate
advisory committee meeting link. The meeting will include slide presentations with audio and
video components to allow the presentation of materials for online participants 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 July 11, 2024, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately 12:15 p.m. and 1:15 p.m.
Eastern Time and will take place entirely through an online meeting platform. 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, and an indication of the approximate time requested to make
their presentation on or before July 2, 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. The contact person will notify interested
persons regarding their request to speak by July 3, 2024.
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 Takyiah Stevenson (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 § 10.19 (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 both in-person and using an
online meeting platform. 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 § 10.19
are met.
Dated: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12532 Filed: 6/6/2024 8:45 am; Publication Date: 6/7/2024]