EC OKs Novartis’ CAR-T Cell Therapy KymriahBy
The European Commission (EC) has approved Novartis’ Kymriah (tisagenlecleucel), a chimeric antigen receptor (CAR) T-cell therapy, for two indications in leukemia and lymphoma. Kymriah was the first CAR-T cell therapy approved by the US Food and Drug Administration (FDA) in August 2017.
The approved indications are for treating pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Novartis says it expects to launch initially in the pediatric ALL indication as it continues to ramp up capacity. Further, the company says timing for Kymriah availability in each country will depend on multiple factors, including the onboarding of qualified treatment centers for the appropriate indications, as well as the completion of national reimbursement procedures. Training is already underway at qualified treatment centers to facilitate safe delivery to patients. Novartis says it “continues to collaborate with national health and reimbursement authorities across Europe on a fair, value-based pricing approach that is sustainable for national healthcare systems.”