Category: Approval/Launch Region: North America · United States Company: Novartis Institutes For Biomedical Research

Novartis Kymriah Gets European Approval As First Car-T Cell Therapy

Novartis Kymriah Gets European Approval As First Car-T Cell Therapy
Novartis Announced That The European Commission (Ec) Has Approved Kymriah (Tisagenlecleucel), A Car-T Cell Therapy, For The Treatment Of Adult Patients With Relapsed Or Refractory (R/R) Follicular Lymphoma (Fl) After Two Or More Lines Of Systemic Therapy.The Approval Follows A Positive Opinion In March By The Committee For Medicinal Products For Human Use (Chmp) Of The European Medicines Agency (Ema) And Is Applicable To All 27 European Union Member States Plus Iceland, Norway And Liechtenstein. This Approval Marks The Third Indication For Kymriah And Makes It The First Car-T Cell Therapy Approved In The Eu For These Patients, Which Include Those With R/R Fl Grade 1, 2 And 3A.

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