Food and Drug Administration

Oncologic Drugs Advisory Committee

December 1, 2004



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Pediatric Acute Leukemia, Dr. Steve Weitman, MD, PhD, ILEX Oncology, Inc. (HTM) (PPT)

Clofarabine CI-F-Ara-A, Dr. Martin Cohen, MD, FDA (HTM) (PPT)

AM Questions for the ODAC Panel (HTM) (PPT)

Open Public Hearing - Morning Session (HTM) (PPT)

Marqibo (Vincristine Sulfate Liposomes Injection), Dr. Fernando Cabanillas, MD, Auxilio Mutuo Cancer Center and Dr. Jane Winter, MD, Northwestern University (HTM) (PPT)

Backup Information (HTM) (PPT)

Vincristine Sulfate Liposome Injection (Marqibo®), Dr. Maitreyee Hazarika, MD, FDA (HTM) (PPT)

PM Questions for the Committee (HTM) (PPT)

Open Public Hearing - Afternoon Session (HTM) (PPT)