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Novartis seeks European approval of cell therapy
[ZURICH] Swiss drugmaker Novartis said on Monday it submitted an application for its cell therapy Kymriah to be approved in Europe for two forms of blood cancer.
Novartis applied to the European Medicines Agency for the therapy to be used in children and young adults with acute lymphoblastic leukemia (ALL) and adult patients with diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant.
The therapy, which Novartis expects to eventually top US$1 billion in annual sales, has been approved by US regulators in pediatric ALL and was submitted in the United States for adults with DLBCL last week.