Kite Pharma, Inc., a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, is moving forward with the company’s KTE-C19, an experimental therapy currently in a pivotal trial for the treatment of refractory, aggressive non-Hodgkin’s Lymphoma (NHL).
The European Medicines Agency (EMA) Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) approved moving forward through a new regulatory initiative called Priority Medicines (PRIME) for KTE-C19.
PRIME is a way for EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early talks with developers of promising medicines in order to optimize development plans, speed up evaluation, and get the medicines to patients quicker.
KTE-C19 is a new treatment in which T-cells from patients are genetically altered to express a chimeric antigen receptor (CAR) aimed at targeting CD19’s antigen, a protein that is expressed on the surface of cells of leukemias and B-cell lymphomas.
“We are honored to be among the first sponsors selected by the CHMP and CAT to participate in an innovative program that fosters development of therapies for patients with serious diseases that have no or only unsatisfactory therapeutic options,” said Dr. Arie Belldegrun, Kite’s chairman, president, and chief executive officer, in a press release. “The potential for KTE-C19 to address the substantial unmet medical need of patients with chemorefractory DLBCL is now recognized by designations from the US and EU regulatory agencies.”
In December 2015, KTE-C19 was granted Breakthrough Therapy Designation by The U.S. Food and Drug Administration for the treatment of patients with transformed follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL) and DLBC.
Kite has three single-arm, multi-center clinical trials to support development of KTE-C19. Among them are: ZUMA-1, a phase 2 study in patients with refractory, aggressive non-Hodgkin’s lymphoma (NHL), including refractory diffuse large B-cell lymphoma (DLBCL); primary mediastinal B-cell lymphoma (PMBCL); and transformed follicular lymphoma (TFL). The company also designed ZUMA-2, a phase 2 study in patients with r/r mantle cell lymphoma, and ZUMA-3, a phase 1/2 study in adult patients with r/r ALL.