Novartis has submitted an application to the European Medicines Agency for its CAR-T therapy CTL019 for two haematological indications.
The drugs giant is seeking permission to market its cell therapy to treat children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.
CAR-T offers a new treatment approach in that it is specifically manufactured for each individual patient. During the process, T cells are drawn from a patient's blood and reprogrammed in the lab to create T cells that are genetically coded to hunt the patient's cancer cells.
“There is an urgent need for innovative treatments for children and young adult patients with these aggressive diseases, who don’t respond to, or have multiple relapses after receiving traditional therapies,” said Barak Palatchi, Oncology general manager, Novartis UK & Ireland.
“Building on our US experience, where we launched the first ever CAR-T therapy, we are working hard to help bring this game-changing therapy to those eligible patients with limited treatment options.”
The submission is based on the Novartis-sponsored global, multicentre, Phase II ELIANA and JULIET trials, which were conducted in collaboration with development and commercialisation partner the University of Pennsylvania.
Novartis says the first-in-class therapy showed an 83 percent overall remission rate in patients with relapsed/refractory ALL, who have limited treatment options and historically poor outcomes.
Back in August CLT019 (tisagenlecleucel) became the first cell therapy to be approved in the US, under the brand name Kymriah, as a treatment for relapsed/refractory ALL, and it has also now been filed in the country for r/r DLBCL.
The firm said it is planning additional regulatory filings for CTL019 in paediatric and young adult patients with r/r ALL and adult patients with r/r DLBCL outside the US and EU next year.
Novartis picked up rights to CTL019 under an agreement with the University of Pennsylvania in 2012, which also gives it worldwide rights to CAR-Ts developed in all cancer indications.
The move is also good news for UK drugmaker Oxford BioMedica, which is the sole manufacturer of the lentiviral vector that encodes CTL019.
Under the companies’ deal, sealed in July 2017, Oxford BioMedica also will supply lentiviral vectors for other undisclosed CAR-T products, and could potentially receive in excess of $100 million from Novartis over the next three years in return, as well as royalties on future sales.