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Novartis gets FDA breakthrough therapy status for CTL019 to treat r/r DLBCL

PBR Staff Writer Published 19 April 2017

Novartis has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its investigational chimeric antigen receptor T cell (CAR-T) therapy, CTL019, to treat adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies.

Earlier, the firm also secured breakthrough therapy status for CTL019 to treat r/r B-cell acute lymphoblastic leukemia (ALL) in pediatric and young adult patients.

The University of Pennsylvania (Penn) had first developed CTL019. In 2012, Novartis and Penn signed a deal to further research, develop and commercialize CAR-T cell therapies such as CTL018 for the investigational treatment of cancers.

Under the deal, Novartis is said to hold the worldwide rights to CARs developed with Penn for all cancer indications.

The approval was based on data from the multi-center Phase II Juliet study, which assessed the efficacy and safety of CTL019 in adult patients with r/r DLBCL.

Juliet is the firm’s second global CAR-T trial, following Eliana study assessing CTL019 in r/r B-cell ALL.

Novartis drug development global head 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."

Separately, Novartis has signed a linical trial agreement with Allergan to carry out a phase IIb study, which will involve the combination of a Novartis FXR agonist and Allergan's cenicriviroc (CVC) to treat non-alcoholic steatohepatitis (NASH).

Image: Novartis’ Basel headquarters. Photo: courtesy of Novartis AG.