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

More Than CAR-T: Hematologic Oncology Pipeline Offers Rich Menu Of Possible Approvals

Executive Summary

Sponsors of established products like Amgen's Kyprolis and Blincyto and Bristol's Sprycel work to bulk up labeling with new indications while FDA reviews at least six novel agents for blood cancers.

You may also be interested in...



Real-World Evidence At US FDA: Bavencio, Blincyto Approvals Point Way Toward Broader Use

Breakthrough-designated oncologics used historical comparator data to determine efficacy threshold for pivotal Phase II studies supporting accelerated approval; Blincyto’s subsequent full approval offers validation with conventional controlled study. 

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

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. 

Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA

The latest regulatory submission news and highlights from our US FDA Performance Tracker.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS121121

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