The European Commission (EC) has granted approval for Novartis’ Kymriah to treat patients with B-cell acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL).
The indication allows the use of the drug in paediatrics and young adults aged up to 25 years with refractory ALL in relapse after transplant or in second or later relapse.
It also covers treatment of adults suffering from relapsed or refractory DLBCL following two or more lines of systemic therapy.
Developed in alliance with the University of Pennsylvania (Penn), Novartis’ Kymriah is a one-time CAR-T cell therapy that utilises a patient’s own T cells to fight cancer.
The drug is manufactured individually for each patient by reprogramming their own immune cells.
Novartis Oncology CEO Liz Barrett said: “The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options.
“Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before remaining steadfast in our goal of reimagining cancer.”
The European approval comes after the review of JULIET and ELIANA global registration CAR-T clinical trials that enrolled patients from eight European countries.
Data revealed strong and durable response rates and a consistent safety profile in two difficult-to-treat patient populations administered with Kymriah.
In 2012, Novartis signed a global partnership with Penn to further research, develop and commercialise CAR-T cell therapies, including Kymriah, as a potential cancer treatment.
The company plans to initially launch Kymriah in the paediatric ALL indication, and the availability in each country is set to vary.
Novartis is also working towards boosting manufacturing capabilities for the drug beyond its facility in Morris Plains, New Jersey, US.
To support the expansion, the company partnered with France-based CELLforCURE and extended collaboration with the Fraunhofer Institute.