Posted by Michael Wonder on 07 Sep 2018
Novartis receives Health Canada approval of its CAR-T cell therapy, Kymriah (tisagenlecleucel)
6 September 2018 - Novartis is working with qualified treatment centres to prepare for the delivery of this treatment for relapsed/refractory paediatric and young adult B-cell ALL and adult relapsed/refractory DLBCL indications.
Novartis is pleased to announce that following a priority review, Health Canada has approved Kymriah (tisagenlecleucel/ CTL019) the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in Canada.
Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two life-threatening cancers that have limited treatment options and historically poor outcomes, demonstrating the critical need for new therapies for these patients.
Health Canada has approved Kymriah for use in pediatric and young adult patients 3 to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) who are refractory, have relapsed after allogenic stem cell transplant (SCT) or are otherwise ineligible for SCT, or have experienced second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
