- April 20, 2018
- 4:00 AM - 11:30 AM ET
April 20, 2018
8:00 a.m. to 3:30 p.m.
FDA White Oak Campus
White Oak Great Room A
10903 New Hampshire Avenue
Silver Spring, Maryland
Public Meetings at the FDA White Oak Campus:
Public Meeting Attendee Information is provided in the following link.
Topic for Discussion:
The FDA Oncology Center of Excellence will hold a public meeting to review and discuss a provisional list of molecular targets to which drugs are being developed for adult cancer indications but which may also be relevant to the growth and/or progression of a cancer which occurs predominantly in children thereby providing a possible rationale for early pediatric evaluation. This meeting is intended for multi-stakeholder participation and input to the Food and Drug Administration as it responds to its FDARA mandate to develop, post on the FDA website, and update regularly such a list to guide sponsors as to which molecular mechanism of action-specific targeted cancer drugs might be considered for early evaluation in children. This list is envisioned to guide sponsors in decisions related to the development of initial Pediatric Study Plans and reaching agreement with the Agency in advance of their new NDA or BLA submissions. In addition to creating the required list, FDA welcomes discussion of additional considerations, including international collaboration, which may be necessary when evaluating the scientific rationale and feasibility of pediatric investigations in response to the amended Pediatric Research Equity Act (PREA) requirements for assessment of molecularly targeted cancer drugs in children. Further input is sought in developing transparent approaches to prioritization of new targeted drugs, particularly of those in the same class where multiple studies in a rare population of patients may neither be necessary or possible.
- Agenda (PDF - 22KB)
- FDA Briefing Document (PDF - 82KB)
- Candidate Pediatric Molecular Targets List (PDF - 105KB)
- References Pediatric Molecular Targets List (PDF - 150KB)
- Candidate Molecular Targets with References (PDF - 210KB)