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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameOncologic Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2018Committee Number35
Original Establishment Date11/28/1990Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*14
Current Charter Date9/1/2018Designated Fed Officer Position Title*Center for Drug Evaluation & Research, FDA
Date Of Renewal Charter9/1/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Lauren
Exempt From Renewal*NoDesignated Federal Officer Middle NameD.
Specific Termination AuthorityDesignated Federal Officer Last Name*Tesh
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharm.D.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-9001
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-847-8533
Committee Type*ContinuingDesignated Federal Officer Email*lauren.tesh@fda.hhs.gov
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot 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 two times in FY-18. On March 7, 2018, the committee discussed supplemental biologic license application (sBLA) 125557/S013, for BLINCYTO (blinatumomab) injection for intravenous use, application submitted by Amgen, Inc. The proposed indication (use) for this product is for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia. Members of the committee agreed that patients with MRD > 0.1% had a very high risk of relapse, but they also noted that the exact population that would benefit from additional therapy is not yet defined. Eight committee members voted “Yes” that the results of MT103-203 demonstrate that for patients with ALL in CR who have MRD > 0.1%, treatment with blinatumomab provides a potential benefit that outweighs the risks from the treatment. Four members voted “No”. It was mentioned that it is not clear where blinatumomab would be used in the treatment cascade given that based on the data presented a “potential” benefit was assumed from trends in the data, but 80% of the patients went to transplantation so the benefit with receiving blinatumomab is confounded. Agency Action: On March 29, 2018, the Agency granted accelerated approval to BLINCYTO (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission, but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. On June 20, 2018, the subcommittee discussed the review and discussion of a list of molecular targets for which evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and a list of those targets deemed unlikely to be associated with the growth or progression of pediatric tumors for which requirement for early pediatric evaluation would be waived. These lists are expected to fulfill the statutory obligation of the Food and Drug Administration Reauthorization Act (FDARA) and provide some guidance to industry in planning for initial Pediatric Study Plan submissions for new drug and/or biologic products in development for cancer in accordance with the amended provisions of the Pediatric Research Equity Act. The committee also reviewed and discussed considerations other than scientific relevance which the FDA will include in decision making with respect to the need and timing of pediatric evaluation of specific new drug and biologic products. The committee also discussed possible criteria and mechanisms for the prioritization by sponsors and the clinical investigator community of select targeted new agents for pediatric evaluation especially in the setting of multiple same in class agents. Preliminary discussion on approaches to coordination and collaboration for pediatric clinical investigations of new agents that might be pursued to efficiently accommodate international regulatory requirements and global pediatric product development. The OPH sessions were: Topic 1: Target List, Topic 2: FDARA Implementation and Topic 3: Mechanisms to assure efficiency and to enhance global coordination through international collaboration. The subcommittee members commented that the list as currently developed should be as fluid and inclusive as possible. By having a more inclusive list, the subcommittee noted it could serve as a guide for early pediatric drug development. The subcommittee suggested adding RET fusions, RET point mutations, KIT mutations, CCND123, CCNE1, STAG2, and histone1H13D onto the list. The subcommittee discussed how industry sponsors can communicate with FDA and study investigators regarding the level of evidence needed to move an agent forward into early phase clinical trials. Public transparency from the sponsors was encouraged since the FDA is not able to share confidential information. The subcommittee mentioned that they can provide advice and recommendations regarding prioritizing targets on the list and it is recommended that the FDA hold workshops more than twice a year, if necessary, with international involvement. The subcommittee clarified with FDA on how sponsor companies receive guidance for conducting clinical trials from the FDA and EMA, then suggested methods for both organizations to collaborate. Agency Action: The Agency is still reviewing recommendations made at this meeting. It is expected that this committee will meet four to six times in FY-19.
Why advice can't be obtained elsewhere?*The committee provides an outside source of scientific expertise in evaluation of clinical trials for oncology drugs. The alternate means of obtaining this advice would be to hire large numbers of scientists on a full time basis at great expense to the government.
Why close or partially close meetings?There were no closed meetings during FY-18.
Recommendation RemarksNo reports are required for this committee.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentFDA approves or chooses not to approve an investigational new medical product.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentN/ANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe 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 CommentN/A
Number Of Recommendations*154Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 154 recommendations from FY-03 through FY-18. See question 20a of the annual report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe 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, and therefore, the Agency has the option of not implementing the advice.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe 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 OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback CommentIt usually does. Product approval issues are first released to the sponsor. When appropriate, information is made available to the public. Actions related to guidance documents or other general matters 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.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$4,191.00Est Payments to Non-Fed Members Next FY*$26,249.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$155,270.00Estimated Payments to Federal Staff*$157,666.00
Payments to Consultants*$8,905.00Est. Payments to Consultants Next FY*$17,499.00
Travel Reimb. For Non-Federal Members*$8,964.00Est Travel Reimb Non-Fed Members nextFY*$48,066.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$10,959.00Est Travel Reimb to Consultants Next FY*$16,761.00
Other Costs$42,347.00Est. Other Costs Next FY*$46,547.00
Total Costs$230,636.00Est. Total Next FY*$312,788.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

  
ActionCommittee System IDCommittee NameFiscal Year
 COM-001647Oncologic Drugs Advisory Committee2017
 COM-002242Oncologic Drugs Advisory Committee2016
 COM-004021Oncologic Drugs Advisory Committee2015
 COM-004395Oncologic Drugs Advisory Committee2014
 COM-005893Oncologic Drugs Advisory Committee2013
 COM-006521Oncologic Drugs Advisory Committee2012
 COM-008158Oncologic Drugs Advisory Committee2011
 COM-008680Oncologic Drugs Advisory Committee2010
 COM-010270Oncologic Drugs Advisory Committee2009
 COM-010763Oncologic Drugs Advisory Committee2008
 COM-011887Oncologic Drugs Advisory Committee2007
 COM-012838Oncologic Drugs Advisory Committee2006
 COM-014006Oncologic Drugs Advisory Committee2005
 COM-014528Oncologic Drugs Advisory Committee2004
 COM-016016Oncologic Drugs Advisory Committee2003
 COM-016499Oncologic Drugs Advisory Committee2002
 COM-017946Oncologic Drugs Advisory Committee2001
 COM-018477Oncologic Drugs Advisory Committee2000
 COM-019848Oncologic Drugs Advisory Committee1999
 COM-020439Oncologic Drugs Advisory Committee1998
 COM-021659Oncologic Drugs Advisory Committee1997