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

US FDA’s Eflornithine Review Is Showcase For Deep Oncology Team

Executive Summary

The advisory committee review of US WorldMeds’ eflornithine for neuroblastoma was remarkable for the unusual nature of the efficacy data to support the NDA – and also for who spoke on behalf of the agency and how effectively they walked the panel through a complex set of issues.

You may also be interested in...



Animal Models: Adcomm Exposes Internal Rift In How FDA Defines ‘Translational’ For Purposes Of Confirmatory Evidence

FDA review staff consider the animal models used in development of US WorldMeds’ eflornithine for neuroblastoma to be translational to humans, even though this does not align with the definition in a September 2023 draft guidance on types of confirmatory evidence.

US WorldMeds’ Neuroblastoma Drug: External Controls, Confirmatory Evidence, And A Concern About Precedent

US FDA officials said the high-quality nature of the patient-level data used in the external control arm, and the use of animal models considered to be translatable, justify reliance upon a nontraditional data package for eflornithine (DFMO) in high-risk neuroblastoma, but some adcomm members worry that an approval will open the door too widely for others to follow.

US FDA Eyes Ways To Improve Conduct, Mitigate Bias In Open-Label Cancer Studies

At advisory committee review of confirmatory trial results for Amgen’s Lumakras, Oncology Center of Excellence’s Richard Pazdur cites need for a broader conversation within the clinical trial community, including educating patients and investigators about the importance of staying on study even when randomized to a comparator arm.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS149021

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