Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Questions Revlimid Dose, Toxicity And Single-Arm Study

This article was originally published in The Pink Sheet Daily

Executive Summary

Oncologic Drugs Advisory Committee will be asked whether Celgene’s single-arm study design is adequate to show clinical benefit in a heterogeneous disease like myelodysplastic syndromes.

You may also be interested in...



Celgene’s Revlimid Phase II Data Sufficient For Full Approval In MDS

FDA’s Oncologic Drugs Advisory Committee recommends full approval of Celgene’s Revlimid for myelodysplastic syndromes despite FDA concerns about trial design, dosing and toxicity.

Celgene’s Revlimid Phase II Data Sufficient For Full Approval In MDS

FDA’s Oncologic Drugs Advisory Committee recommends full approval of Celgene’s Revlimid for myelodysplastic syndromes despite FDA concerns about trial design, dosing and toxicity.

MGI/SuperGen’s Dacogen Is “Approvable” Pending Transfusion Data Analysis

Companies expect to submit requested data to FDA early in the fourth quarter for the myelodysplastic syndromes therapy.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062873

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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