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Stock Update (NASDAQ:KITE): Kite Pharma Inc Receives Positive Opinions for Orphan Drug Designation in the European Union (EU) for KTE-C19 in Three Additional Hematological Indications


Kite Pharma Inc (NASDAQ:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions recommending KTE-C19 for designation as an orphan medicinal product for the treatment of ALL, CLL/SLL, and FL. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite previously received orphan drug designation for KTE‑C19 for the treatment of diffuse large B‑cell lymphoma (DLBCL) in both the US and the EU, as well as COMP positive opinions for orphan drug designation in the EU for primary mediastinal B-cell lymphoma (PMBCL) and mantle cell lymphoma (MCL).

“The orphan drug designation is an important regulatory milestone as we further our development...