Skip to content

FDA Breakthrough Therapy Designation: Novartis Gets A 5th

July 8, 2014

Novartis receives on July 7th, the FDA Breakthrough Therapy Designation (BTD) for CTL09. The BTD is for the treatment of pediatric and adult patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL). CTL09 is an:

“ … investigational Chimeric Antigen Receptor (CAR) therapy … (that) uses technology to reprogram a patient’s own T cells to “hunt” cancer cells that express specific proteins, called CD19. After they have been reprogrammed, the T cells are re-introduced into the patient’s blood; they proliferate and bind to the targeted CD19+ cancer cells and destroy them.”

The University of Pennsylvania’s Perelman School of Medicine (UPPSM) filed for the BTD. UPPSM and Novartis have a global agreement to research, develop, and commercialize personalized CAR T Cell Therapies for cancers.

This is the 46th BTD announced by a sponsor company and the 5th BTD for Novartis :

Num Drug Name Indication
1 LDK378 (Zykadia) ** ALK+

Non-Small

Cell Lung

Cancer (NSCLC)

2 Serelaxin Acute Heart

Failure

3 Bimagrumab Sporadic

Inclusion

Body Myositis

4 Bexsero Vaccine Meningococcal BDisease
5 Personalized Cell Therapy CTL019 Relapsed/refractory acute lymphoblastic leukemia (r/r ALL)

.

** Zykadia receives FDA Approval in April 2014.

Just last week, Amgen receives the FDA BTD for the investigational bispecific T cell engager (BiTE) antibody Blinatumomab, for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor Acute Lymphoblastic Leukemia (ALL).

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Glowing heart (114668824)” by 29cm from Hong Kong (Glowing heart) [CC-BY-SA-2.0] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

Advertisements
Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: