Meetings of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee

1
Meetings of the Pediatric Subcommittee of the
Oncologic Drugs Advisory Committee

• September 2000
• Discussion of methods that may be used to
  describe and link tumor types
• April 2001
• Hematologic tumors and the Pediatric Rule
• June 2001
• Solid tumors and central nervous system
  malignancies and the Pediatric Rule
• November 2001
• Study designs and extrapolation
• October 2002
• Timing of clinical studies

2
General Principles from International Conference
on Harmonization Efficacy Topic-11

• Pediatric patients should be given medicines that
  have been properly evaluated for their use in the
  intended population
• Product development programs should include
  pediatric studies when pediatric use is
  anticipated
• Pediatric development should not delay adult
  studies nor adult availability
• Shared responsibility among companies, regulatory
  authorities, health professionals, and society as
  a whole.

3
ICH E-11

• Diseases Predominantly or Exclusively Affecting
  Pediatric Patients
• ...the entire development program will be
  conducted in the pediatric population except for
  initial safety and tolerability data, which will
  usually be obtained in adults.

4
ICH E-11

• Serious or Life-Threatening Diseases, Occurring
  in Both Adults and Pediatric Patients, for Which
  There Are Currently No or Limited Therapeutic
  Options
• medicinal product development should begin
  early in the pediatric population, following
  assessment of initial safety data and reasonable
  evidence of potential benefit.

5
Charge to Committee

• What information is necessary to consider
  exposing children with cancer to an
  investigational agent ?