FACA

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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	2021	Committee Number	35
Original Establishment Date	11/28/1990	Committee Status	Chartered
Actual Termination Date		Committee URL	http://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FY	No	Presidential Appointments*	No
Terminated This FY	No	Max Number of Members*	14
Current Charter Date	9/1/2020	Designated Fed Officer Position Title*	Designated Federal Officer
Date Of Renewal Charter	9/1/2022	Designated Federal Officer Prefix
Projected Termination Date		Designated Federal Officer First Name*	She-Chia
Exempt From Renewal*	No	Designated Federal Officer Middle Name	S.
Specific Termination Authority		Designated Federal Officer Last Name*	Chen
Establishment Authority*	Authorized by Law	Designated Federal Officer Suffix	PharmD
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Phone*	(301) 796-9001
Effective Date Of Authority*	11/28/1990	Designated Federal Officer Fax*	(301) 847-8533
Exempt From EO 13875 Discretionary Cmte	Exempt: Consumer Product Safety Cmte	Designated Federal Officer Email*	she-chia.chen@fda.hhs.gov
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. The Office of Oncology Drug Products also uses committee members as subject matter experts, on an as needed basis.
How is membership balanced?*	Members are selected from academic and practice settings and include practitioners knowledgeable in the field of general oncology, pediatric oncology, hematological oncology, immunology oncology, biostatistics, and other related professions. The Committee includes one technically qualified voting member who is identified with consumer interests. The Committee may also include one non-voting member who is identified with industry interests.
How frequent & relevant are cmte mtgs?*	The Committee met four times in FY-21. On February 9, 2021, the Committee discussed supplemental biologics license application (sBLA) 125514/s-089, for KEYTRUDA (pembrolizumab), submitted by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. The proposed indication (use) for this product is for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery. Committee members unanimously voted, “Yes” (10 to 0), that a regulatory decision on pembrolizumab in combination with multi-agent chemotherapy for neoadjuvant treatment followed by pembrolizumab monotherapy for adjuvant treatment of high-risk early-stage TNBC should be deferred until further data are available from future analyses of KEYNOTE-522. The majority of the members expressed concerns about the existing strength of evidence from an ongoing phase III clinical trial using the magnitude of improvement in the co-primary endpoint of pathologic complete response (pCR) in this patient population and treatment setting. Agency Action: On July 26, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. On April 27, 2021, the Committee received 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. The majority of the Committee (7 to 2) voted in favor of maintaining the indication for atezolizumab in combination with nab-paclitaxel for the treatment of unresectable locally advanced or metastatic TNBC. The Committee members who voted in favor of maintaining the indication cited the overall survival (OS) benefit observed in IMpassion130 as their reason for supporting the indication, despite not being statistically significant. A few members considered whether IMpassion132 would be sufficient to confirm benefit. Agency Action: The Agency is currently evaluating recommendations made during the meeting. On April 28, 2021, during the morning session, the Committee received updates on the following product: BLA 125514/S-017, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharp & Dohme Corp., indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. A slight majority of members (5 to 3) voted in favor to maintain the indication for pembrolizumab for the first-line treatment of cisplatin-ineligible advanced/metastatic urothelial carcinoma, although several members noted that they would prefer the indication to include only patients who are unable to receive platinum-containing chemotherapy rather than patients who may receive carboplatin-based chemotherapy. Members who voted against maintaining the indication cited the negative results of the confirmatory trial KN-361. Agency Action: The Agency is currently evaluating recommendations made during the morning session of the meeting. On April 28, 2021, during the afternoon session, the Committee received updates on the following product: BLA 761034/S-001, trade name TECENTRIQ (atezolizumab), submitted by Genentech, Inc., indicated for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. A majority of members (10 to 1) voted in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma pending final OS results from IMvigor130. The member who voted against maintaining the indication expressed concern that while IMvigor130 showed statistical significance for PFS, there may not be a demonstrated clinically meaningful improvement. Agency Action: The Agency is currently evaluating recommendations made during the afternoon session of the meeting. On April 29, 2021, during the morning session, the Committee received updates on the following product: BLA 125514/S-024, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharp & 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. A majority of members (2 to 6) voted against maintaining the indication for pembrolizumab in PD-L1 CPS ≥ 1 gastric/GEJ adenocarcinoma (third-line or greater) pending conduct or completion of additional trials. The Committee members acknowledged the unmet needs of patients in the third-line or greater setting; however, the Committee members raised concerns over the data in the KN-061 and KN-062 trials that did not demonstrate benefit when pembrolizumab was compared to chemotherapy. Agency Action: The Agency is currently evaluating recommendations made during the morning session of the meeting. On April 29, 2021, during the afternoon session, the Committee received updates on the following products: (1) BLA 125514/S-042, trade name KEYTRUDA (pembrolizumab), submitted by Merck Sharp & Dohme Corp., indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; and (2) 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. For Topic 1, the members (8 to 0) voted unanimously for maintaining the indication for the monotherapy use of pembrolizumab in patients previously treated with sorafenib pending conduct or completion of additional trials. Specifically, the Committee members considered that although KN-240 did not demonstrate benefit when pembrolizumab was compared to placebo, the Accelerated Approval (AA) should be maintained pending the results of KN-394. For Topic 2, a slight majority of members (4 to 5) voted against maintaining the indication for the monotherapy use of nivolumab in patients previously treated with sorafenib pending conduct or completion of additional trial(s). Those Committee members who voted “Yes” mirrored concerns over the unmet need for 15 to 20% of patients with HCC who are not eligible to receive the atezolizumab/bevacizumab combination due to the increased risk of bleeding associated with bevacizumab. Several members who voted “No” stated that the data from CheckMate-459 did not prove statistical or clinical benefit. Agency Action: The Agency is currently evaluating recommendations made during the afternoon session of the meeting. On May 11, 2021, the Pediatric SubCommittee of the Oncologic Drugs Advisory Committee met and discussed the development and successful implementation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) as a tool for eliciting the patient’s voice in oncology clinical trials to more accurately determine tolerability and toxicity of drugs under investigation. The Subcommittee also addressed the challenges of capturing this type of data across the age spectrum of the pediatric population and possible generalizability of the data. It considered approaches to address concerns about excluding the patient voice of young children deemed incapable of self-reporting. Six discussion questions were taken place. The Subcommittee also focused on approaches to investigators and commercial sponsors to use the Pediatric PRO-CTCAE in toxicity assessment moving forward. Some SubCommittee members agreed that PRO assessments can provide clinicians with a better understanding of the burden of therapy in children. Some SubCommittee members raised concerns about the diversity of the data, whether PRO assessments would accurately reflect comprehensive and equitable input across the spectrum of pediatric patients with cancer. Based on the context that PRO-CTCAE data are retrospective and descriptive, the majority of the SubCommittee members agreed that the PRO-CTCAE data would be beneficial to include children’s voices, along with caregivers reported observable symptoms to evaluate symptom management. Some SubCommittee members raised a concern regarding whether use of PRO-CTCAE would require significant infrastructure and resources. The SubCommittee members noted that collecting this type of data might pose operational challenges and that perhaps some tools could facilitate incorporation of PRO-CTCAE assessments into clinical trials. The majority of the SubCommittee members agreed that it would be worthwhile to incorporate this data into the FDA’s Project Patient Voice. The SubCommittee did not provide any recommendations or consideration for this discussion question as the majority of the SubCommittee members considered this question was similar to Questions 4 and 6. The SubCommittee members noted that the pediatric PRO-CTCAE tool could contribute to implementation of optimal supportive care guidelines and development of research strategies for children. Agency Action: The Agency published the FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, Guidance for Industry on May 24, 2021. On May 12, 2021, the Pediatric SubCommittee of the Oncologic Drugs Advisory Committee met and discussed real-world evidence (RWE) for regulatory use in pediatrics, real-world data (RWD) resources, and RWD and RWE to advance pediatric safety assessments of oncology drug products in children within the context of the FDA framework for RWE. Potential data sources and publicly available platforms, including those made possible through the development and implementation of the National Cancer Institute’s Childhood Cancer Data Initiative, were discussed. The potential for use of data sources to construct external controls to evaluate effectiveness of investigational products was considered given the frequent dependence on single-arm studies due to extremely small study populations, now exaggerated by molecularly defined subtypes of the rare cancer types that occur in children. The majority of the SubCommittee members agreed that RWD and RWE would help better characterize molecular subtypes of pediatric cancers. SubCommittee members noted some of the current limitations include the quality of available datasets, specifically genetic data sets that could help predict better clinical responses and identify biomarkers for future clinical trials. Some SubCommittee members noted that it is important to recognize that there are other efforts in pediatric oncology underway to include clinical and genomic data in addition to the Childhood Cancer Data Initiative (CCDI). SubCommittee members commented that there might be some issues with GPDR which might be more restrictive. Given the complexity of regulations in different countries, it was commented that this might affect the ability to obtain data. SubCommittee members suggested incorporation of the patient voice through validated tools such as PRO-CTCAE to provide patient input on adverse events to alleviate some of the existing challenges. It was further commented that the RWD and RWE could potentially be used to inform clinicians regarding adverse reactions to medications. Agency Action: The Agency published the FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, Guidance for Industry on May 24, 2021. On June 24, 2021, the Committee discussed biologics license application (BLA) 761209 for retifanlimab injection, submitted by Incyte Corporation. The proposed indication (use) for this product is for the treatment of adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy. A discussion question and a vote question were presented. A majority of the Committee members cautioned that the POD1UM-202 clinical trial did not appear to demonstrate a magnitude of effect on overall response rate (ORR) that is clinically meaningful and reasonably likely to predict clinical benefit in patients with recurrent advanced or metastatic squamous cell carcinoma of the anal canal. Particularly, some Committee members commented that there were historical accelerated approvals of PD-1 or PD-L1 inhibitors based on low response rates; however, the confirmatory trials were not successful in demonstrating benefit. One Committee member shared that this disease state was virally driven, and it was important to recognize that as it may affect the magnitude of effect on ORR when compared to other diseases being studied in trials investigating checkpoint inhibitors. A majority of the Committee members (13 to 4) voted, “Yes,” that a regulatory decision on retifanlimab for the treatment of advanced or metastatic SCAC should be deferred until further data are available from clinical trial POD1UM-303. These members expressed concerns about the existing strength of evidence from the single-arm phase 2 POD1UM-202 trial. The Committee members who voted “No” noted that this drug product could provide a treatment option for this patient population, particularly the HIV (+) subset. Agency Action: The Agency is currently evaluating recommendations made during the meeting. It is expected that this Committee will meet four to six times during FY-22.
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-21.
Recommendation Remarks	There were no reports required for this Committee in FY-21. Although the current charter states that the committee shall hold meetings approximately six 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 product.
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*	181	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 181 recommendations from FY-03 through FY-21. See section Recommendation/Justifications of the annual report for specific accomplishments.	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.	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

Payments to Non-Federal Members*		Est Payments to Non-Fed Members Next FY*
Payments to Federal Members*		Est. Payments to Fed Members Next FY*
Payments to Federal Staff*		Estimated Payments to Federal Staff*
Payments to Consultants*		Est. Payments to Consultants Next FY*
Travel Reimb. For Non-Federal Members*		Est Travel Reimb Non-Fed Members nextFY*
Travel Reimb. For Federal Members*		Est Travel Reimb For Fed Members*
Travel Reimb. For Federal Staff*		Est. Travel Reimb to Fed Staff Next FY*
Travel Reimb. For Consultants*		Est Travel Reimb to Consultants Next FY*
Other Costs		Est. Other Costs Next FY*
Total Costs	$0.00	Est. Total Next FY*	$0.00
Date Cost Last Modified		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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