• Center on Health Equity & Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

Amgen's Blinatumomab Get's Breakthrough Status for ALL

Article

The drug is the first in it's class - an antibody designed to engage 2 different targets simultaneously.

Biotechnology giant Amgen has filed its investigational cancer immunotherapy blinatumomab in the US for the treatment of certain forms of acute lymphoblastic leukaemia (ALL).

Specifically, the Biologic License Application seeks approval to market the drug for patients with Philadelphia-negative (Ph-) relapsed/refractory B-precursor forms of the aggressive blood/bone marrow cancer.

Blinatumomab is the first of Amgen’s BiTE antibody constructs, a novel immunotherapy approach under which antibodies are modified to engage two different targets simultaneously. The drug has already been awarded both ‘Orphan’ and ‘Breakthrough’ status by the Food and Drug Administration, indicating that it could offer a significant advance over available therapies on at least one clinically significant endpoint.

Read the complete article: http://bit.ly/1r0YkpF

Source: PharmaTimes

Related Videos
Joshua K. Sabari, MD
Nicoletta Colombo, MD, PhD
Dr Brian Mulherin
Dr Brian Koffman
Dr Brian Mulherin
Dr Vivek Subbiah
Dr Scott Soefje
Dr Scott Soefje
Dr Mark Fendrick
Related Content
© 2025 MJH Life Sciences
AJMC®
All rights reserved.