11.09.2015 14:15:59
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Kite Pharma Receives Positive Opinion For Orphan Drug Designation For KTE-C19
(RTTNews) - Kite Pharma Inc (KITE) on Friday announced that the European Medicines Agency or EMA Committee for Orphan Medicinal Products or COMP has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of PMBCL and MCL.
Commenting on KTE-C19, the company said it is an investigational therapy in which a patient's T cells are genetically engineered to express a chimeric antigen receptor or CAR designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. No other product candidate currently has orphan drug designation for the treatment of PMBCL in the EU.
Kite previously received orphan drug designation for KTE-C19 for the treatment of diffuse large B-cell lymphoma or DLBCL in both the US and the EU.
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