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Novartis submits second application to FDA for CAR-T therapy
October 31, 2017 / 6:36 AM / 17 days ago

Novartis submits second application to FDA for CAR-T therapy

ZURICH, Oct 31 (Reuters) - Swiss pharma group Novartis said on Tuesday it ‍submitted an application to the U.S. Food and Drug Administration (FDA) for Kymriah in adult patients suffering from a form of blood cancer.

Novartis said it submitted a supplemental biologics license application for Kymriah for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for an autologous stem cell transplant.

This would be the second indication for the first-ever chimeric antigen receptor T cell (CAR-T) therapy that was approved by the FDA in August against acute lymphoblastic leukemia in patients up to 25 years old. Novartis also plans to submit an application with European authorities this year. (Reporting by Silke Koltrowitz, editing by John Miller)

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