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FDA Breakthrough Therapy Designation #57: Juno Therapeutics’ Immunotherapy For ALL

November 24, 2014

Juno Therapeutics, a Seattle-based clinical-stage start-up biotechnology company, is developing novel cellular immunotherapies to treat cancer. The company announces November 24th that its JCAR015 Chimeric Antigen Receptor (CAR) product candidate receives the FDA Breakthrough Therapy Designation (BTD) for treatment of relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r ALL).

Juno Therapeutics’ collaboration partner, Memorial Sloan Kettering Cancer Center (MSKCC) in New York, filed for the FDA BTD. Since the creation of Juno Therapeutics in December 2013, the start-up company raises more than $300 million.

Just a week ago, FDA Orphan Drug Designation (ODD) was given to JCAR015 and the company also filed an Initial Public Offering (IPO) for its public stock.  All 3 of Juno Therapeutics CAR T-cell product candidates that are currently in clinical trials are based on CAR technology that “employs the body’s immune system to attack cancer cells”. The following are Juno Therapeutics CAR T-cell product candidates :

•   JCAR014 for refractory Chronic Lymphocytic Leukemia (CLL), non-Hodgkin’s Lymphoma (NHL), & ALL (Fred Hutchinson Cancer Research Center, Seattle)

•   JCAR015 for r/r ALL (MSKCC)

•   JCAR017 for r/r CD19-positive pediatric leukemia (Seattle Children’s Hospital).

Juno Therapeutics will present data on these clinical trials at the 54th Annual Meeting of the American Society of Hematology (ASH) next week in San Francisco.

In July 2014, the FDA gives Novartis’ CAR T-cell therapy a Breakthrough Therapy Designation (BTD) for its personalized cell therapy CTL019, for relapsed/refractory Acute Lymphoblastic Leukemia (r/r ALL). CTL019 also receives FDA Orphan Drug Designation (ODD) in January 2014.



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.

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