FACACLASSIC

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”

HHS - 35 - Oncologic Drugs Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Oncologic Drugs Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	35
Original Establishment Date	11/28/1990	Committee Status	Chartered
Actual Termination Date		Committee URL	http://www.fda.gov/AdvisoryCommittees/Committee...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	14
Terminated This FY	No	Designated Fed Officer Position Title*	Acting Designated Federal Officer
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	9/1/2024	Designated Federal Officer First Name*	Yvette
Date Of Renewal Charter	9/1/2026	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Waples
Exempt From Renewal*	No	Designated Federal Officer Suffix	Pharm.D.
Specific Termination Authority		Designated Federal Officer Phone*	(301) 796-9034
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	(301) 847-8533
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Email*	yvette.waples@fda.hhs.gov
Effective Date Of Authority*	11/28/1990
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The Committee reviews and evaluates 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 of Food and Drugs.
How is membership balanced?*	Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunology oncology, biostatistics, and other related professions. Members will be invited to serve for overlapping terms of up to four years. 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. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.
How frequent & relevant are cmte mtgs?*	In FY-25, the Committee held 2 meetings. 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 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 trials should be required in the future to assess the effectiveness of therapies 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 he proposed dosage in the proposed patient population. Agency Action: The Agency is reviewing recommendations made at the meeting. It is expected that the Committee will meet 4-6 times during FY-26.
Why advice can't be obtained elsewhere?*	Members of the Committee are drawn from academia, research and/or clinical practice. Their advice and input lends credibility to FDA regulatory decisions. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientist on a full-time basis at a maximum rate of compensation.
Why close or partially close meetings?	The Committee held no closed meetings during FY-25.
Recommendation Remarks	Although the current charter states that the Committee shall hold meetings approximately 4-6 times a year, this is only an estimation based on data from previous years. As the FDA convenes advisory committees regarding based on the needs of the Agency, it should not be construed as an exact figure.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	Yes
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	Yes
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve an investigational new medical products.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	N/A	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The utilization of the Oncologic Drugs Advisory Committee enabled the Agency to obtain required and frequently scarce professional services from medical and scientific experts not otherwise available to the Agency; and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the Committee resulted in advice for the improvement of public health, for which it is difficult to assign a financial value.	Grants Review Comment	N/A
Number Of Recommendations*	208	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 208 recommendations from FY-03 through FY-25.	Access Agency Website	Yes
% of Recs Fully Implemented*	84.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, therefore, the Agency has the option of not implementing the advice. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, the Agency has the option of not implementing the advice.	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	When appropriate, information is made available to the public. Actions related to guidance documents or other general matters or issues are available publicly when implemented https://www.fda.gov/advisory-committees	Narrative Description*	FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Oncologic Drugs Advisory Committee supports FDA's strategic priorities by reviewing and evaluating 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 of Food and Drugs. This supports the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:40 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Food and Drugs Food and Drugs Health Health Care Safety Treatment

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