Food and Drug Administration

Center for Drug Evaluation and Research

Pediatric Subcommittee

of the Oncologic Drugs Advisory Committee

Advisors and Consultants Conference Room

5630 Fishers Lane

Rockville, Maryland

Tentative Agenda June 28, 2001

 

 

The purpose of this meeting is to provide advice to the FDA on when pediatric solid tumors and CNS malignancies may be considered to be the same indication as adult malignancies.

The Pediatric Rule of 1998 states that there is a Federal mandate to perform pediatric studies if the indication under review for a marketing license exists in children.

Based on conventional criteria, the different tumor types seen in adults and children may appear to limit the application of the 1998 Pediatric Rule to pediatric oncology. Data other than conventional histology may extend the consideration of what is a pediatric disease and what is an adult disease.

 

 

8:00 Call to Order and Opening Remarks Victor Santana, M.D.

Chair, Pediatric Subcommittee of ODAC

Welcome Richard Pazdur, M.D.

Director, Division of Oncology Drug Products

Introduction of Committee

Conflict of Interest Statement Karen M. Templeton-Somers, Ph.D.

Executive Secretary, ODAC

8:15 Open Public Hearing ( 30 minutes allocated unless public participation does not last that long )

8:45 Charge to the Committee Steven Hirschfeld, M.D., Ph.D.

Medical Officer, DODP

8:50 Considerations in Linking Adult Victor Santana, M.D.

and Pediatric Solid Tumors St. Jude Children’s Research Hospital

9:15 Challenges and Considerations in Linking Henry S. Friedman, M.D.

and Pediatric CNS Malignancies Duke University Medical Center

9:40 Discussion

10:00 Break

10:15 Perspectives on Sarcomas Michael P. Link, M.D.

Stanford University School of Medicine

 

Robert S. Benjamin, M.D.

University of Texas M.D. Anderson Cancer Center

10:45 Discussion

Questions to the Committee

I. For sarcomas

    1. What general principles could be used to relate sarcomas in adults to sarcomas in children?
    2. Which of the following adult diseases has a pediatric counterpart and what is the basis?
      1. Soft tissue sarcomas
      2. Tumors of bone
      3. Tumors of the vasculature
      4. Gastrointestinal carcinomas
    1. Are there pediatric sarcomas that have an adult counterpart that is not commonly classified as an adult sarcoma, but as some other type of adult malignancy such as a carcinoma?

 

11:45 Lunch

 

12:30 Open Public Hearing ( 30 minutes allocated unless public participation does not last that long )

1:00 Perspectives on Lung Tumors and Neuroblastoma Frederic Kaye, M.D.

National Cancer Institute

C. Patrick Reynolds, M.D., Ph.D.

Children’s Hospital of Los Angeles

1:30 Discussion

Questions to the Committee

II. For lung tumors and neuroendocrine tumors:

    1. What general principles could be used to relate malignancies in adults to neuroendcrine malignancies in children?
    2. Which of the following adult diseases has a pediatric counterpart and what is the basis?

1. Small cell lung cancer

2. Non-small cell lung cancer

3. Mesothelioma

4. Bronchiogenic tumors

5. Endocrine tumors

            1. Thyroid carcinoma
            2. Multiple endocrine neoplasias

6. Adrenal tumors other than neuroblastoma

    1. Are there pediatric neuroendocrine tumors that have an adult counterpart that is not commonly classified as an adult neuroendocrine tumor, but as some other type of adult malignancy such as a carcinoma?

2:00 Perspectives on CNS Malignancies Susan Staugaitis, M.D., Ph.D.

The Cleveland Clinic Foundation

Howard A. Fine, M.D.

National Institutes of Health

2:30 Break

2:45 Discussion

 

Questions to the Committee

III. For CNS malignancies

    1. What general principles could be used to relate CNS malignancies in adults to CNS malignancies in children?
    2. Which of the following adult diseases has a pediatric counterpart and what is the basis?
    3. (1) Central nervous system tumors

      (a) Neuroectodermal tumors

      (b) Nerve sheath tumors

      (c) Meningeal tumors

      (d) Germ cell tumors

      (e) Germinomas

      (f) Cyst like lesions

      (g) Sellar tumors

      (i) Pituitary adenoma

      (ii) Crainiopharyngioma

    4. Are there pediatric CNS malignancies that have an adult counterpart that is not commonly classified as an adult CNS malignancy, but as some other adult malignancy such as a germ cell tumor or other type of tumor?

 

3:40 Summary Comments Paul A. Meyers, M.D.

Memorial Sloan-Kettering Cancer Center

Victor A. Levin, M.D.

University of Texas MD Anderson Cancer Center

4:00 Adjourn