Novartis has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for CTL019 (tisagenlecleucel) for two indications.
The company’s application is for the treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (ALL), as well as for adult patients with r/r diffuse large B-cell lymphoma (DLBCL).
The immunocellular therapy and a one-time treatment, CTL019 uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence. It uses a patient’s own T-cells to fight cancer.
Novartis Drug Development global head and chief medical officer Vas Narasimhan said: “Since the historic FDA approval of Kymriah, formerly CTL019, we have launched, manufactured and supplied this highly individualised immunocelluar therapy in a commercial setting and the submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world.
“We look forward to working with the EMA to make CTL019 available to the children and adults who may benefit from this novel therapy.”
DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for 40% of all NHL cases globally.
If left untreated, r/r DLBCL has a life expectancy of three to four months.
Novartis’ submission of MAA is based on the global, multicenter, phase II ELIANA and JULIET trials sponsored by the company.
As part of the ELIANA global CAR-T cell therapy registration trial, patients were examined in 25 centres in the US, Canada, Australia, Japan and the EU, including Austria, Belgium, France, Germany, Italy, Norway, and Spain.
Next year, the company plans to make additional regulatory submissions for CTL019 in pediatric and young adult patients with r/r B-cell ALL and adult patients with r/r DLBCL outside the US and EU.