[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14125-14127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1440]


Oncologic Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

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 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 April 27, 2021, from 1 p.m. to 3:45 
p.m. Eastern Time, on April 28, 2021, from 9 a.m. to 3 p.m. Eastern 
Time, and on April 29, 2021, from 9 a.m. to 5:30 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19 
pandemic, all meeting participants will be joining this advisory 
committee meeting via an online teleconferencing 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-2020-N-1440. The docket will close on April 
26, 2021. Submit either electronic or written comments on this public 
meeting by April 26, 2021. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before April 26, 2021. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. Eastern Time

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at the end of April 26, 2021. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if 
they are postmarked or the delivery service acceptance receipt is on or 
before that date.
    Comments received on or before April 20, 2021, 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-2020-N-1440 for ``Oncologic Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments.'' 
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. Please call 240-402-7500 ahead of 
the meeting time to verify access.
     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 Yu and 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, 
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 the 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 coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform.
    The committee will hear updates on certain supplemental biologics 
license applications (sBLAs) approved under 21 CFR 601.40 (subpart E, 
accelerated approval regulations) with confirmatory trial(s) that have 
not verified clinical benefit. These updates will provide information 
on: (1) The status and results of confirmatory clinical studies for a 
given indication; and (2) any ongoing and planned trials. Confirmatory 
studies are post-marketing studies to verify and describe the clinical 
benefit of a drug after it receives accelerated approval. Based on the 
updates provided, the committee will have a general discussion focused 
on next steps for each product including whether the indications should 
remain on the market while additional trial(s) are conducted.
    On April 27, 2021, the committee will receive updates on the 
following product: BLA 761034/S-018, for TECENTRIQ (atezolizumab), 
submitted by Genentech, Inc., indicated in combination with paclitaxel 
protein-bound for the treatment of adult patients with unresectable 
locally advanced or metastatic triple-negative breast cancer (TNBC) 
whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune 
cells (IC) of any intensity covering >=1% of the tumor area), as 
determined by an FDA-approved test.
    On April 28, 2021, the committee will receive updates on the 
following products: (1) BLA 125514/S-017, trade name KEYTRUDA 
(pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for 
the treatment of patients with locally advanced or metastatic 
urothelial carcinoma who are not eligible for cisplatin-containing 
chemotherapy; and (2) BLA 761034/S-001, trade name TECENTRIQ 
(atezolizumab), submitted by Genentech, Inc., indicated for patients

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with locally advanced or metastatic urothelial carcinoma who are not 
eligible for cisplatin-containing chemotherapy.
    On April 29, 2021, the committee will receive updates on the 
following products: (1) BLA 125514/S-024, trade name KEYTRUDA 
(pembrolizumab), submitted by Merck Sharpe & Dohme Corp., indicated for 
the treatment of patients with recurrent locally advanced or metastatic 
gastric or gastroesophageal junction adenocarcinoma whose tumors 
express PD-L1 [Combined Positive Score (CPS) >=1] as determined by an 
FDA-approved test, with disease progression on or after two or more 
prior lines of therapy including fluoropyrimidine- and platinum-
containing chemotherapy and if appropriate, HER2/neu-targeted therapy; 
(2) BLA 125514/S-042, trade name KEYTRUDA (pembrolizumab), submitted by 
Merck Sharpe & Dohme Corp., indicated for the treatment of patients 
with hepatocellular carcinoma (HCC) who have been previously treated 
with sorafenib; and (3) BLA 125554/S-041, trade name OPDIVO 
(nivolumab), submitted by Bristol-Myers Squibb Company, indicated as a 
single agent for the treatment of patients with hepatocellular 
carcinoma (HCC) who have been previously treated with sorafenib.
    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 meeting room 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 components to allow the 
presentation of materials 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 submitted to the Docket (see 
ADDRESSES) on or before April 20, 2021, will be provided to the 
committee. Oral presentations from the public will be scheduled from 
approximately 2:55 p.m. to 3:15 p.m. Eastern Time on April 27, 2021. 
Oral presentations from the public will also be scheduled between 
approximately 10:55 a.m. to 11:15 a.m., and 2:10 p.m. to 2:30 p.m. 
Eastern Time on April 28, 2021. Oral presentations from the public will 
also be scheduled between approximately 10:50 a.m. to 11:10 a.m., 1:55 
p.m. to 2:15 p.m., and from 4:40 p.m. to 5 p.m. Eastern Time on April 
29, 2021. 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 April 12, 2021. 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 April 13, 
2021.
    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 Yu and 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. app. 2).

    Dated: March 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05202 Filed 3-11-21; 8:45 am]
BILLING CODE 4164-01-P


