Genetically modified T-cell therapy granted enhanced EMA regulatory pathway: KTE-C19


Kite Pharma granted access to PRIME regulatory support for KTE-C19 to treat chemorefractory DLBCL

In a press release, Kite Pharma announced that it is?among first sponsors selected to participate in the EMAs enhanced regulatory program for investigational therapies that promise significant advances against serious diseases. ?The?European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to Kite Pharma’s newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL).

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.

KTE-C19? has been granted Breakthrough Therapy Designation status by the US FDA for the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). KTE-C19 has also secured Orphan Drug Designation in the U.S. and the EU for DLBCL, PMBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL).

“The potential for KTE-C19 to address the substantial unmet medical need of patients with chemorefractory DLBCL is now recognized by designations from the U.S. and EU regulatory agencies,” said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. ?Dr. Belldegrun added “We look forward to working closely with the CHMP and CAT as we advance our multi-center ZUMA studies and move toward the KTE-C19 marketing authorization application process.” Read more…

More About DLBCL and Other Common Types of B-Cell Lymphomas

DLBCL is the most common type of non-Hodgkin lymphoma, it is fast-growing, and chemotherapy is often very effective. However, several subtypes exist and they can affect the prognosis and treatment options.? About 1/3 of patients relapse and it is most likely to occur within the first two years post-treatment.

Secondary treatments are available for patients who relapses or whose disease is refractory, including autologous (in most cases) or allogeneic stem cell transplant.

Other common types of B-cell lymphomas include the slow-growing follicular lymphoma (FL) and Chronic lymphocytic leukemia (CLL), the aggressive Mantle cell lymphoma (MCL) and Burkitt lymphoma.? Learn more?