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news.Kite Pharma, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) products for the treatment of cancer, has announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of diffuse large B cell lymphoma (DLBCL).
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KTE-C19 is an anti-CD19 CAR T cell therapy that involves genetically modifying a patient’s T cells to express a CAR that is designed to target CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
The COMP, a committee of the EMA, adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission for endorsement of the opinion.
Orphan drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available.
In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
DLBCL is an aggressive type of non-Hodgkin lymphoma for which the treatment options include chemotherapy, anti-CD20 antibodies, and, in selected patients, autologous transplant.
Although most patients with DLBCL can be cured by either chemotherapy or transplant, a significant proportion of patients have disease that is resistant to chemotherapy or that relapses after transplant. For these patients with refractory DLBCL, there is a substantial unmet need for more effective therapies.