Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS061126

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel