FDA grants Breakthrough Therapy designation to Novartis CTL019 for DLBCL
Novartis’ investigational chimeric antigen receptor T-cell (CAR-T) therapy, CTL019, has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) to treat adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The CTL019 will be administered to those patients who have failed two or more prior therapies.
In CAR-T cell therapy, T-cells are drawn from a patient's blood and reprogrammed in the laboratory to create genetically coded T-cells that kill cancer cells and other B-cells that exhibits a particular antigen.
CTL019 has previously received this designation for the treatment of r/r B-cell acute lymphoblastic leukaemia (ALL) in paediatric and young adult patients.
DLBCL is one of the common forms of lymphoma that accounts nearly 30% of all non-Hodgkin lymphoma cases.
Novartis global head of drug development and chief medical officer Vas Narasimhan said: “At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with r/r DLBCL.
“We look forward to working closely with the FDA to help bring this potential new treatment option to patients as soon as possible.”
The Breakthrough Therapy designation was provided on the basis of multi-centre Phase II JULIET study (NCT02445248) that evaluated the efficacy and safety of CTL019 in adult patients with r/r DLBCL.
The awarded designation also requires Novartis to expedite the development and review of CTL019 in adults with r/r DLBCL.
In 2012, Novartis and the University of Pennsylvania, which first developed CTL019, entered a global collaboration to develop and commercialise CAR-T cell therapies, including CTL019.
Last month, FDA accepted Novartis' Biologics License Application filing and granted priority review for CTL019 to treat r/r paediatric and young adult patients with B-cell ALL.
With this award, Novartis has received 14 Breakthrough Therapy designations since the FDA started the programme in 2013.
Image: Lymphocyte B-cell. Photo: courtesy of Blausen Medical.