FDA Breakthrough Therapy Designation: Novartis Gets A 5th
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 :
|1||LDK378 (Zykadia) **||ALK+
|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).
Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.