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Novartis: seeks OK from EU for CAR-T therapy.

(CercleFinance.com) - Novartis has reached another regulatory milestone for CTL019, the world's first-ever FDA approved CAR-T therapy, by submitting a marketing authorisation for two indications in Europe.

The application deals with the treatment of children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).

CTL019 - a novel immuno-cellular therapy that uses a patient's own T cells to fight cancer - has been approved by the US FDA for the treatment of young patients with leukemia in August, a first for this type of treatment.

This morning Novartis also published new long-term Cosentyx data for patients with ankylosing spondylitis, showing that almost 80% of patients treated have no radiographic progression of the spine at four years.

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