JCAR017 designated as “Breakthrough Therapy” by FDA

When I was searching for a CAR-T trial in early 2015, I had assumed they were more or less the same, and the important thing was to just get into one, as time was of the essence.  Since I was already a MSK (Memorial Sloan-Kettering) patient, and it was relatively close to home, I just enrolled there.  (We did also visit with Dr. Stephen Schuster at U. Penn, since he had published some very promising early CAR-T results at ASH 2014 with fNHL patients like myself.)

Fast forward to today, and we now see that Juno Therapeutics (pharma of my CAR-T therapy at MSK) has had one trial shut down (JCAR015) due to patient deaths, but has now had another trial (JCAR017) designated as a Breakthrough Therapy by the FDA.  So perhaps the choice of CAR-T trial matters more than I had realized!  Of course, this is all with the benefit of hindsight.  Still, it points up the fact that, while the choice to proceed with a CAR-T therapy itself can be logical and well-considered, a successful outcome can often depend on the serendipitous choice of which CAR-T trial.

— Ben


FDA Grants JCAR017 Breakthrough Designation for Non-Hodgkin Lymphoma
http://www.onclive.com/web-exclusives/fda-grants-jcar017-breakthrough-designation-for-nonhodgkin-lymphoma


Clinical Trial of T-Cell Therapy for B-cell Lymphomas Aided by FDA and EMA
http://lymphomanewstoday.com/2016/12/22/clinical-tests-of-t-cell-therapy-jcar017-advanced-by-fda-and-ema-for-b-cell-lymphomas


JCAR017 gets PRIME access, breakthrough designation (login required)
http://www.hematologytimes.com/p_article.do?id=6723&section=Lymphomas

 

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