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

Amgen Will Try To Convince ODAC Of Minimal Disease Endpoint To Show Blincyto's Efficacy

Executive Summary

US FDA unconvinced that minimal residual disease finding is predictive of clinical benefit, but Amgen's quest for new Blincyto indication to treat minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia can get boost if Oncology Drugs Advisory Committee supports the primary endpoint. 

You may also be interested in...



Amgen's Postmarketing Trials For Blincyto Likely To Form Stringent Dataset On Minimal Residual Disease

US FDA requiring randomized trials in adults and children as part of Blincyto’s supplemental accelerated approval in minimal residual disease; along with Amgen's data, agency will have results from NCI-funded trials to evaluate efficacy.

FDA Grants Blincyto Accelerated Approval Based On MRD Response Endpoint

Amgen sees the approval as a platform to expand blinatumomab into other hematologic malignancies using similar approaches.

Amgen's Blincyto Has 'Potential Benefit' For MRD ALL, But Approval Chances Remain Unclear

US FDA's oncology advisory committee seems to feel Blincyto has potential in minimal residual disease-positive acute lymphoblastic leukemia, but panel was not asked specifically about approval; a decision could hinge on how agency reviewers interpret committee's comments.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS122643

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