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

Cancer Trial Endpoints: Minimal Residual Disease Eyed As Surrogate

Executive Summary

More work needs to be done to validate MRD as predictive of clinical outcomes in hematological malignancies before it can be used as the basis for accelerated approval, FDA and other stakeholders say.

You may also be interested in...



Minimal Residual Disease Inches Closer To Supporting Myeloma Accelerated Approvals

US FDA’s oncology advisory committee will discuss two meta-analyses supporting use of MRD as a surrogate endpoint to support accelerated approval in multiple myeloma trials.

Endpoint Milestone In AML: Kronos’ Entospletinib Trial Will Rely On Residual Disease

Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.

Bladder Cancer: More Questions Than Answers With pCR Endpoint

Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119122

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