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

CTI's Pixuvri Strategy After FDA Rejection: Expanded Access, Combo Trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Cell Therapeutics plans to pursue an expanded access program for its non-Hodgkin's lymphoma drug Pixuvri (pixantrone) while it conducts a new combination therapy trial to satisfy concerns raised in FDA's April 9 "complete response" letter

You may also be interested in...



Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows

By targeting a population with an unmet medical need that would qualify for review under FDA's accelerated approval regulations, GlaxoSmithKline and Genmab transcended a "suboptimal" development program and "uncertainty" regarding the magnitude of treatment effect to bring their anti-CD20 monoclonal antibody Arzerra (ofatumumab) to market, FDA review documents show

Context Is Key To Accelerated Approval In Oncology, Arzerra Review Shows

By targeting a population with an unmet medical need that would qualify for review under FDA's accelerated approval regulations, GlaxoSmithKline and Genmab transcended a "suboptimal" development program and "uncertainty" regarding the magnitude of treatment effect to bring their anti-CD20 monoclonal antibody Arzerra (ofatumumab) to market, FDA review documents show

Cell Therapeutics Should Consider Different Trial Design For Pixuvri, FDA's Pazdur Says

The odds were against Cell Therapeutics from the beginning of the Oncology Drugs Advisory Committee meeting, as FDA officials had concluded that the single, incomplete clinical trial did not provide enough evidence of efficacy.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS004428

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