Advisory Committee; Oncologic Drugs Advisory Committee; Renewal

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the September 1, 2028, expiration date.

Full Text

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<title>Federal Register, Volume 91 Issue 161 (Friday, August 21, 2026)</title>
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[Federal Register Volume 91, Number 161 (Friday, August 21, 2026)]
[Notices]
[Pages 54332-54335]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-0008]


Advisory Committee; Oncologic Drugs Advisory Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Oncologic Drugs Advisory Committee by the Commissioner 
of Food and Drugs (the Commissioner). The Commissioner has determined 
that it is in the public interest to renew the Oncologic Drugs Advisory 
Committee for an additional 2 years beyond the charter expiration date. 
The new charter will be in effect until the September 1, 2028, 
expiration date.

DATES: Authority for the Oncologic Drugs Advisory Committee will expire 
on September 1, 2026, unless the Commissioner formally determines that 
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Advisory Committee Oversight and 
Management Staff, Office of the Chief Scientist, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver 
Spring, MD 20993-0002, (301) 796-8220, <a href="/cdn-cgi/l/email-protection#1051535f5d434365727d796363797f7e63507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="c283818d8f9191b7a0afabb1b1abadacb182a4a6a3ecaaaab1eca5adb4">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65, 21 CFR 14.40, 
and approval by the Department of Health and Human Services and by the 
General Services Administration, FDA is announcing the renewal of the 
Oncologic Drugs Advisory Committee (the Committee). The Committee is a 
discretionary Federal advisory committee established to provide advice 
to the Commissioner. The Committee advises the Commissioner or designee 
in discharging responsibilities as they relate to helping to ensure 
safe and effective drugs for human use and as required, any other 
product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of cancer and makes appropriate 
recommendations to the Commissioner.
    The Committee shall consist of a core of at least thirteen voting 
members including the Chair. Subject to legal and regulatory 
requirements, members and the Chair are selected by and serve at the 
discretion of the Commissioner or designee. Each member, including the 
Chair, will be selected from among authorities knowledgeable in the 
fields of general oncology, pediatric oncology, hematologic oncology, 
immunology oncology, biostatistics, and other related professions.
    Members may be invited to serve for terms of up to four years, or 
for less time in the discretion of the Commissioner or designee. Non-
Federal members of this committee will serve as Special Government 
Employees or representatives. Federal members will serve as Regular 
Government Employees or Ex-Officios.
    In addition to the voting members, the Commissioner or designee may 
identify consumer and/or industry representatives to join the Committee 
(or serve as alternate representatives) as non-voting representative 
member(s), via a process consistent with legal and regulatory 
requirements. Individuals currently employed at FDA-regulated 
companies, such as pharmaceutical and medical device manufacturers, 
shall not be selected to serve as members of the Committee unless this 
Committee is expected to address issues for which inclusion of an 
industry representative is required by statute. If this Committee 
includes an industry representative, the Commissioner or designee will 
determine whether to invite them to participate in meetings on a case-
by-case basis, according to applicable legal and regulatory 
requirements.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees to 
serve temporarily as voting members and to designate Special Government 
Employees to serve temporarily as

[[Page 54333]]

voting members when: (1) expertise is required that is not available 
among current voting standing members of the Committee (when additional 
voting members are added to the Committee to provide needed expertise, 
a quorum will be based on the combined total of regular and added 
members), or (2) to comprise a quorum when, because of unforeseen 
circumstances, a quorum is or will be lacking.
    A quorum for the Committee is a majority of the current voting 
members present at the time, provided that FDA may specify a quorum 
that is less than a majority of the current voting members because of 
the size of the Committee and the variety in the types of issues that 
it will consider, or other reason determined appropriate in accordance 
with legal and regulatory requirements. 21 CFR 14.22(d).
    If functioning as a medical device panel, an additional non-voting 
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in 
addition to the voting members.
    Members appointed to an advisory committee serve for the duration 
of the committee, or until their terms expire, they resign, or they are 
removed from membership by the Commissioner or designee. Committee 
members' terms may be ended prior to their date of expiration, for 
reasons determined to be good cause. Good cause includes excessive 
absenteeism from committee meetings, a demonstrated bias that 
interferes with the ability to render objective advice, failure to 
abide by established procedures, or violation of other applicable rules 
and regulations.
    The Pediatric Subcommittee of the Oncologic Drugs Advisory 
Committee (Pediatric Subcommittee) is a permanent subcommittee of the 
Oncologic Drugs Advisory Committee described in Section 15 of the Best 
Pharmaceuticals for Children Act, Pub. L. 107-109. The Pediatric 
Subcommittee reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of pediatric cancers and provides advice on new 
and emerging therapeutic alternatives for children with cancer. Its 
functions include evaluating and, to the extent practicable, 
prioritizing new and emerging pediatric cancer therapies; providing 
recommendations and guidance to help ensure timely access to promising 
new cancer therapies; and advising on ways to improve consistency in 
the availability of new therapeutic agents.
    The Pediatric Subcommittee shall consist of up to 11 voting members 
appointed by the Secretary of Health and Human Services from the 
membership of the Pediatric Advisory Committee and the Oncologic Drugs 
Advisory Committee. As needed for the scientific and ethical 
consideration of pediatric cancer topics, the Pediatric Subcommittee 
may include or request participation from pediatric oncology 
specialists, including specialists from the National Cancer Institute, 
statisticians, representatives of pediatric cancer patients or patient-
family organizations, representatives of the nursing community, 
representatives of the pharmaceutical industry, pediatric 
pharmacologists, and other scientific experts. Relevant expertise 
includes pediatric oncology, general oncology, hematologic oncology, 
immunologic oncology, clinical pharmacology, biostatistics, pediatric 
therapeutics, patient and family perspectives, and related scientific 
and ethical expertise.
    Further information regarding the most recent charter and other 
information can be found at <a href="https://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/oncologic-drugs-advisory-committee-charter">https://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/oncologic-drugs-advisory-committee-charter</a> or by contacting the Advisory Committee Oversight and 
Management Staff (see FOR FURTHER INFORMATION CONTACT). Because the 
committee's name and description of duties remain unchanged, 21 CFR 
14.100 will not be amended.
    Renewal Requirements and Justification: The Commissioner has 
determined that renewal of the Oncologic Drugs Advisory Committee is in 
the public interest. This determination is based on the Committee's 
essential role in providing independent expert advice on the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of cancer, the continued need for specialized 
expertise in this therapeutic area, and the Committee's demonstrated 
value in supporting FDA's regulatory mission. The following information 
supports this determination in accordance with applicable legal and 
regulatory requirements.

Public Interest Determination

    Pursuant to 41 CFR 102-3.60(a), to establish, renew, reestablish, 
or merge a discretionary (agency discretion) advisory committee, an 
agency must first consult with the General Services Administration's 
Committee Management Secretariat (the Secretariat) and, as part of the 
consultation, provide a written public interest determination approved 
by the head of the agency to the Secretariat with a copy to the Office 
of Management and Budget. In addition, pursuant to 41 CFR 102-3.35, an 
agency shall follow the same consultation process and document in 
writing the same determination of need before creating a subcommittee 
under a discretionary committee that is not made up entirely of members 
of a parent advisory committee.
    Information on the following factors for the committee is provided 
to the Secretariat to demonstrate that renewing the committee is in the 
public interest:
    1. Annual budget.
    Annual budget and expected costs: $286,942.
    a. Federal personnel on a full-time equivalent (FTE) basis.
    The estimated person years of Federal staff support is .40 at an 
estimated annual cost of $70,265.
    b. Other Federal internal costs.
    The anticipated total value in USD of other internal costs, such as 
cost associated with IT supplies for meeting is $73,958.
    c. Proposed payments to members.
    The estimated annual payment to members is $39,090.
    d. Proposed number of members.
    The anticipated number of members is thirteen.
    e. Reimbursable costs.
    The estimated annual reimbursable costs, including travel and 
related expenses for members, is $41,159.
    2. If applicable, the total dollar value of grants expected to be 
recommended during the fiscal year N/A.
    3. Criteria for selecting members to ensure the committee has the 
necessary expertise and fairly balanced membership.
    Ensuring Necessary Expertise: Members must have background, 
education, and experience commensurate with the committee's function of 
advising FDA on the existing and relevant evidence of benefits and 
risks of marketed and investigational human drug products for use in 
the treatment of cancer and related specialties. Scientific and 
technical competence is critical. Nominees should be acknowledged 
experts with demonstrated skills in critical evaluation of data and 
effective communication. As outlined in the committee charter, the 
membership should include authorities knowledgeable in the fields of 
general oncology, pediatric oncology, hematologic oncology, immunology 
oncology, biostatistics, and other related professions, as well as 
needed consumer and industry representation. FDA also follows the 
requirements in section

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505(n)(3) regarding membership of drug product advisory committees. (21 
U.S.C. 355(n)(3)). Additionally, as outlined in the committee charter, 
relevant expertise for members of the pediatric subcommittee includes 
pediatric oncology, general oncology, hematologic oncology, immunologic 
oncology, clinical pharmacology, biostatistics, pediatric therapeutics, 
nursing, industry perspectives, patient and family perspectives, and 
related scientific and ethical expertise.
    Ensuring Fair Balance: Appointments are made without 
discrimination. The committee is reviewed in totality for balance, 
characterized by inclusion of necessary knowledge, insight, and 
scientific perspective from the relevant community or expertise area. 
Nominations are sought from all geographic locations within the United 
States and its territories, and from diverse sources including 
professional and scientific societies, academia, government agencies, 
industry and trade associations, consumer and patient organizations, 
and current Agency staff.
    4. List of all other Federal advisory committees of the agency.
    FDA maintains the following Federal advisory committees:

<bullet> Anesthetic and Analgesic Drug Products Advisory Committee
<bullet> Antimicrobial Drugs Advisory Committee
<bullet> Blood Products Advisory Committee
<bullet> Cardiovascular and Renal Drugs Advisory Committee
<bullet> Cellular Tissue and Gene Therapies Advisory Committee
<bullet> Dermatologic and Ophthalmic Drugs Advisory Committee
<bullet> Device Good Manufacturing Practice Advisory Committee
<bullet> Digital Health Advisory Committee
<bullet> Drug Safety and Risk Management Advisory Committee
<bullet> Endocrinologic and Metabolic Drugs Advisory Committee
<bullet> Genetic Metabolic Disease Advisory Committee
<bullet> Medical Devices Advisory Committee
<bullet> National Mammography Quality Assurance Advisory Committee 
(Administratively Inactive)
<bullet> Nonprescription Drugs Advisory Committee
<bullet> Obstetrics, Reproductive and Urologic Drugs Advisory Committee
<bullet> Pediatric Advisory Committee
<bullet> Peripheral and Central Nervous System Advisory Committee
<bullet> Pharmacy Compounding Advisory Committee
<bullet> Psychopharmacologic Drugs Advisory Committee
<bullet> Pulmonary-Allergy Drugs Advisory Committee
<bullet> Risk Communication Advisory Committee (Administratively 
Inactive)
<bullet> Science Board to the Food and Drug Administration
<bullet> Technical Electronic Product Radiation Safety Standards 
Committee
<bullet> Tobacco Products Scientific Advisory Committee
<bullet> Vaccines and Related Biological Products Advisory Committee

    5. Justification that the information or advice provided by the 
Federal advisory committee or subcommittee is not available from 
another Federal advisory committee, another Federal Government source, 
or any other more cost-effective and less burdensome source.
    The Oncologic Drugs Advisory Committee provides independent expert 
advice to FDA on the safety and effectiveness of marketed and 
investigational human drug products for use in the treatment of cancer. 
The topics considered by the Oncologic Drugs Advisory Committee require 
specialized expertise in the fields of general oncology, pediatric 
oncology, hematologic oncology, immunology oncology, biostatistics, and 
related specialties that is not within the primary scope of other FDA 
advisory committees. Potential topics that may need committee input 
include products related to the topics outlined in Section (6) below. 
These and other issues cannot be appropriately addressed by another 
standing committee without diminishing the depth and relevance of the 
expert input provided to the Agency.
    6. If the consultation is a committee renewal, a summary of the 
previous accomplishments of the committee and the reasons it needs to 
continue.
    Summary of previous Accomplishments:
    In the last two years, ODAC met three times: On April 30, 2026, the 
Oncologic Drugs Advisory Committee met to discuss the following: On the 
morning of April 30, 2026, the Committee discussed new drug application 
(NDA) 220359, for camizestrant tablets, submitted by AstraZeneca 
Pharmaceuticals LP. The proposed indication (use) is in combination 
with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for 
the treatment of adult patients with hormone receptor (HR)-positive, 
human epidermal growth factor receptor 2 (HER2)-negative, locally 
advanced or metastatic breast cancer upon emergence of ESR1 mutation 
during first-line endocrine-based therapy, based on an FDA approved 
test. Agency Action: The Agency is reviewing recommendations made at 
the meeting.
    On the afternoon of April 30, 2026, the Committee discussed 
supplemental new drug application (sNDA) 218197/S-004, for Truqap 
(capivasertib) tablets, submitted by AstraZeneca Pharmaceuticals LP. 
The proposed indication (use) is in combination with abiraterone for 
the treatment of adult patients with metastatic hormone-sensitive 
prostate cancer (mHSPC) that is PTEN-deficient as detected by an FDA-
approved test. Agency Action: The Agency is reviewing recommendations 
made at the meeting.
    Between May 20-21, 2025, the Oncologic Drugs Advisory Committee met 
to discuss the following: On the morning of May 20, 2025, the Committee 
discussed 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). The issues the Committee discussed focused on how the 
differential results observed in the Asian and Non-Asian regions 
impacted the overall interpretation of the STARGLO trial results and 
the generalizability to a U.S. patient population. The Committee 
members were in near unanimous agreement (8 Noes and 1 Yes) that the 
STARGLO population and trial results are not applicable to the proposed 
U.S. patient population. Agency Action: The Agency is reviewing 
recommendations made at the meeting.
    On the afternoon of May 20, 2025, the Committee discussed 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). The issues 
the Committee discussed focused on the clinical meaningfulness of the 
efficacy endpoints assessed in the AQUILA trial, and the benefit-risk 
of daratumumab hyaluronidase for the intended high-risk (SMM) 
population. The majority of Committee members (6 Yeses and 2 Noes) 
agreed that the results from the AQUILA trial provided sufficient 
evidence to support a favorable benefit-risk profile for Dara SC for 
patients with high-risk SMM. Agency Action: The

[[Page 54335]]

Agency is reviewing recommendations made at the meeting.
    On the morning of May 21, 2025, the Committee discussed new drug 
application (NDA) 215793, for UGN-102 (mitomycin) intravesical 
solution, submitted by UroGen Pharma, Inc. The proposed indication 
(use) is for the treatment of adult patients with low-grade 
intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The 
issues the Committee discussed focused on whether randomized 
trialsshould be required in the future to assess the effectiveness 
oftherapies in LG-IR-NMIBC given the uncertainty regarding 
interpretation of study results. The Committee was split with a slight 
majority voting that the overall benefit-risk of UGN-102 was not 
favorable in patients with recurrent LG-IR-NMIBC (5 Noes and 4 Yeses). 
Agency Action: The Agency is reviewing recommendations made at the 
meeting.
    On the afternoon of May 21, 2025, the Committee discussed 
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). The issues the Committee discussed focused on whether efficacy 
should be formally evaluated in a biomarkernegative population when the 
biomarker is predictive of response and the prevalence of the 
biomarker-negative group is high. The Committee members were in 
unanimous agreement (8 Noes, and 0 Yeses) that the results from the 
TALAPRO-2 trial were not sufficient to conclude a favorable benefit-
risk profile for adding talazoparib to enzalutamide in patients with 
non-HRRm mCRPC. Agency Action: The Agency is reviewing recommendations 
made at the meeting.
    On July 17, 2025, the Committee discussed BLA 761440, belantamab 
mafodotin submitted by GlaxoSmithKline LLC, for the treatment of adults 
with multiple myeloma in combination with bortezomib and dexamethasone 
in patients who have received at least one prior line of therapy; and 
in combination with pomalidomide and dexamethasone in patients who have 
received at least one prior line of therapy including lenalidomide. The 
majority of Committee members (5 Noes, 3 Yeses) agreed that the overall 
benefit-risk of belantamab mafodotin in combination with bortezomib and 
dexamethasone was not favorable at the proposed dosage in the proposed 
patient population. The Committee was nearly in unanimous agreement (7 
Noes, 1 Yes) that the overall benefit-risk of belantamab mafodotin in 
combination with pomalidomide and dexamethasone was not favorable at 
the proposed dosage in the proposed patient population. Agency Action: 
The Agency is reviewing recommendations made at the meeting.
    7. Explanation of why the committee/subcommittee is essential to 
the conduct of agency business.
    Reasons for Continuation: The committee plays a critical role in 
enabling FDA to meet the requirements of sections 505(n)(1) and (s)(1) 
of the Federal Food, Drug, and Cosmetic Act by providing expert 
scientific advice and recommendations. Without the Oncologic Drugs 
Advisory Committee, FDA's ability to obtain external expert input on 
issues related to the approval and regulation of the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of cancer would be significantly limited.
    In conclusion, this public interest determination documents that 
renewing the committee is in the public interest, essential to the 
conduct of agency business, and that the information to be obtained is 
not already available through another advisory committee or source 
within the Federal Government.
    This notice is issued under the Federal Advisory Committee Act as 
amended (5 U.S.C. 1001 et seq.). For general information related to FDA 
advisory committees, please visit us at <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17084 Filed 8-20-26; 8:45 am]
BILLING CODE 4164-01-P


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