[Federal Register Volume 90, Number 88 (Thursday, May 8, 2025)]
[Notices]
[Pages 19488-19490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08060]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1107]
Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments--Supplemental
Biologics License Application 761309/S-001, for COLUMVI (glofitamab)
Injection; Supplemental Biologics License Application 761145/S-029, for
DARZALEX FASPRO (daratumumab and hyaluronidase) Injection; New Drug
Application 215793, for (mitomycin) Intravesical Solution; Supplemental
New Drug Application 211651/S-013, for TALZENNA (talazoparib) Capsules
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 May 20, 2025, from 8 a.m. to 5 p.m.
and May 21, 2025, from 8 a.m. to 5 p.m. Eastern Time.
ADDRESSES: 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/
[[Page 19489]]
AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2025-N-1107. The docket will close on May 23,
2025. 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 May
23, 2025. 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 May 13, 2025, 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-2025-N-1107 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments--
Supplemental Biologics License Application 761309/S-001, for COLUMVI
(glofitamab) Injection; Supplemental Biologics License Application
761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase)
Injection; New Drug Application 215793, for (mitomycin) Intravesical
Solution; Supplemental New Drug Application 211651/S-013, for TALZENNA
(talazoparib) Capsules.'' 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: Jessica Seo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7699, 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: The meeting presentations will be
heard, viewed, captioned, and recorded through an online
teleconferencing and/or video conferencing platform.
On the morning of May 20, 2025, the Committee will discuss
supplemental biologics license application (sBLA) 761309/S-001, for
COLUMVI (glofitamab) injection, submitted by Genentech, Inc. The
proposed indication (use) is in combination with gemcitabine and
oxaliplatin for the treatment of adult patients with relapsed or
refractory diffuse large B-cell lymphoma, not otherwise specified
(DLBCL, NOS) who are not candidates for autologous stem cell transplant
(ASCT).
On the afternoon of May 20, 2025, the Committee will discuss sBLA
761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase)
injection, for subcutaneous use, submitted by Janssen Biotech, Inc. The
proposed indication (use) is as monotherapy for the treatment of adult
patients with high-risk smoldering multiple myeloma (SMM).
On the morning of May 21, 2025, the Committee will discuss new drug
application (NDA) 215793, for (mitomycin) intravesical solution,
submitted by UroGen Pharma, Inc. The
[[Page 19490]]
proposed indication (use) is for the treatment of adult patients with
low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-
NMIBC).
On the afternoon of May 21, 2025, the Committee will discuss
supplemental new drug application (sNDA) 211651/S-013, for TALZENNA
(talazoparib) capsules, submitted by Pfizer Inc. The proposed
indication (use) is in combination with enzalutamide for the treatment
of adult patients with metastatic castration-resistant prostate cancer
(mCRPC).
FDA regrets that it was unable to publish this notice 15 days prior
to the Oncologic Drugs Advisory Committee meeting due to technical
issues. Because there is a need for an immediate meeting of the
Committee, including the time-sensitive need for input and public
discussion on the meeting subject, and because qualified members of the
committee were available at this time and scheduled to participate in
the meeting, the Agency concluded that there are exceptional
circumstances that support holding this meeting without the customary
15-day public notice.
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 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.
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 May 13, 2025, will be provided to the Committee. Oral presentations
from the public will be scheduled between approximately 10:30 a.m. to
11 a.m. and 3:25 p.m. to 3:55 p.m. Eastern Time on May 20, 2025, and
between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m.
Eastern Time on May 21, 2025. 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 May 12, 2025. 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 May 13, 2025. 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 Jessica Seo (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 Sec. 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 Sec.
10.19 are met.
Dated: May 2, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08060 Filed 5-7-25; 8:45 am]
BILLING CODE 4164-01-P