Genzyme Clolar Confirmatory Pediatric Study Should Enroll Early Relapse Leukemia Patients, Cmte. Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Focus on earlier stage disease would enlarge potential pediatric population for study. FDA’s Oncology Pediatric Subcommittee also recommends that primary trial endpoints include remission induction rate.
You may also be interested in...
Lilly’s Gemzar For Ovarian Cancer To Be Reviewed by Oncologic Cmte.
FDA’s Oncologic Drugs Advisory Committee will review Gemzar on March 15. The committee’s Pediatric Oncology Subcommittee will discuss Novartis’ Exjade post-marketing study commitments on March 14.
Lilly’s Gemzar For Ovarian Cancer To Be Reviewed by Oncologic Cmte.
FDA’s Oncologic Drugs Advisory Committee will review Gemzar on March 15. The committee’s Pediatric Oncology Subcommittee will discuss Novartis’ Exjade post-marketing study commitments on March 14.
Pediatric Studies Of Clolar, Neulasta, Kepivance To Be Discussed By Oncology Subcommittee
Genzyme and Amgen will share their challenges in design and implementation of post-marketing pediatric studies, such as patient accrual problems and changes in standard of care, at FDA's Oncologic Drugs Advisory Committee on Oct. 20.