publication date: Sep. 7, 2018

Drugs & Targets

Kymriah gets European approval for B-cell ALL and diffuse large B-cell lymphoma indications

The European Commission has approved the Novartis agent Kymriah (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

This approval was based on the review of the only two global registration CAR-T clinical trials, JULIET and ELIANA, which included patients from eight European countries. In these trials, Kymriah demonstrated strong and durable response rates and a consistent safety profile in two difficult-to-treat patient populations.

Kymriah is one of the first PRIME-designated therapies to receive EU approval. PRIME is a program launched by the European Medicines Agency to enhance support for the development of medicines that target an unmet medical need and help patients benefit as early as possible from therapies that may significantly improve their quality of life.

Novartis expects to launch initially in the pediatric ALL indication, 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 key qualified treatment centers to facilitate safe and seamless delivery to patients; and Novartis 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.

The EC approval of Kymriah in pediatric and young … Continue reading Kymriah gets European approval for B-cell ALL and diffuse large B-cell lymphoma indications

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