The FDA has granted breakthrough therapy designation to Novartis’ investigational chimeric antigen receptor T cell (CAR-T) therapy, CTL019, for the treatment of patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who have failed two or more prior therapies.
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“At Novartis, we are eager to unlock the full potential of CTL019, including the potential to help patients with r/r DLBCL,” affirmed Vas Narasimhan, global head of drug development and chief medical officer, Novartis. “We look forward to working closely with the FDA to help bring this new potential new treatment option to patients as soon as possible.”
This new indication is the second one for which CTL019 has received breakthrough therapy designation. The first was for the treatment of r/r B-cell acute lymphoblastic leukaemia (ALL) in paediatric and young adult patients.
The designation is based on data from the multicentre Phase II JULIET study, which is evaluating efficacy and safety of the therapy in adult patients with r/r DLBC. Findings from this study are expected to be presented at an upcoming medical congress.
CTL019 was first developed by the University of Pennsylvania and in 2012 a collaboration was formed between the university and Novartis to research, develop and commercialise the CAR-T cell therapies for the investigational treatment of cancers. Earlier this year, Novartis revealed that the FDA had accepted its biologics licence application filing.
“We are encouraged by the FDA’s recognition by the FDA’s recognition in the potential of CTL019 for this indication, which follows our promising studies of this therapy for ALL and the FDA filing by Novartis in paediatric and young adult ALL that received priority review,” added Dr Carl June, director of the Center for Cellular Immunotherapies in the Perelman School of Medicine at the University of Pennsylvania. “Work with our collaborators at trial sites across the world is paving a path to bring personalised cell therapies to more patients with these devastating blood cancers.”