Pediatric Oncology Subcommittee

of the Oncologic Drugs Advisory Committee (ODAC)

October 20, 2005

FDA Briefing Document

AM Session

1. Mission: Pediatric Oncology Subcommittee of the ODAC

2002 Best Pharmaceuticals for Children Act (BPCA) – Section 15, page 12
(also available at: www.fda.gov/cder/pediatric/PL107-109.pdf)

2. Clolar™ (clofarabine) for Intravenous Infusion (approved December 28, 2004)

a. Approval Letter

b. Package Insert

c. Link to Medical Officer Review and other regulatory documents:
www.fda.gov/cder/foi/nda/2004/21-673_Clolar.htm

3. Introduction to Pediatric Research Equity Act (PREA) and BPCA

a. Guidance for Industry: How to Comply with the Pediatric Research Equity Act

b. See BPCA (item 1 above)

4. Kepivance™ (palifermin) (approved December 15, 2004)

a. Approval Letter

b. Package Insert

c. Link to Medical Officer Review and other regulatory documents:
www.fda.gov/cder/foi/nda/2005/125103s000_KepivanceTOC.htm

5. Neulasta™ (pegfilgrastim) (approved January 31, 2002)

a. Approval Letter

b. Package Insert

c. Patient Package Insert

d. Link to Medical Officer Review and other regulatory documents
www.fda.gov/cder/foi/nda/2002/125031_0000_NeulastaTOC.htm

PM Session

6. BPCA Off-Patent Process

a. Off-Patent Process

· See BPCA (Item 1 on previous page – Section 2 and 3, pages 1-4)

· BPCA Slides – A. Zajicek, M.D., Pharm.D; NICHD/NIH

b. Update on Vincristine and Dactinomycin

· Grant Proposal from J. Barrett, Ph.D., FCP

c. Daunorubicin

· 2005 41^st Annual Meeting of the American Society of Clinical Oncology (ASCO)
abstract from S. Berg, M.D.: Abstract 8519 - Impact on body composition on
pharmacokinetics of doxorubicin in pediatric patients: A Glaser Pediatric Research
Network study

d. Other off-patent drugs for pediatric cancer

· List of off-patent drugs

· List of off-patent drugs according to therapeutic class

7. Future Subcommittee Topics

· List of previous Pediatric Subcommittee meetings