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The FDA grants CTL019 Breakthrough Therapy Designation for adult patients with relapsed/refractory Diffuse Large B-Cell Lymphoma

Apr 18, 2017

On 18 thApril 2017, CTL019 (also known as tisagenlecleucel) was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ( FDA) for the treatment of adult patients with R/R DLBCL who have failed two or more previous therapies.

Novartis’CTL019 is an investigational Chimeric Antigen Receptor (CAR) T-cell therapy and the Breakthrough Therapy Designation is based on early data from the phase II, single arm, multicenter JULIET study ( NCT02445248). The trial is aiming to assess the safety and efficacy of CTL019 in adult patients with R/R DLBCL, it has an estimated enrollment of 130 patients, and the estimated primary completion date is January 2024.

CTL019 already holds Breakthrough Therapy Designation for pediatric and young adult patients with R/R B-cell Acute Lymphoblastic Leukemia (ALL).

  1. Sector Publishing Intelligence. Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough Therapy designation for treatment of adult patients with r/r DLBCL. 2017 Apr 18. http://www.sectorpublishingintelligence.co.uk/news/1693895/novartis+cart+cell+therapy+ctl019+receives+fda+breakthrough+therapy+designation+for+treatment+of+adult+patients+with+rr+dlbcl. [Accessed 2017 Apr 18].