SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite Pharma, Inc. (Nasdaq:KITE) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to its newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL). PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. 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.
"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," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. “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. 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."
The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to KTE-C19 for the treatment of patients with DLBCL, primary mediastinal B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL) in December 2015.
About the Priority Medicines Initiative
Access to the Priority Medicines initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with unmet medical need. The criteria for the Priority Medicines initiative require early clinical evidence that the therapy offers a therapeutic advantage over existing treatments or benefits patients without treatment options. This designation provides appointment of a rapporteur, early dialogue and scientific advice at key development milestones, and the potential to qualify products for accelerated review earlier in the application process.
About Kite's ZUMA Clinical Programs for KTE-C19
KTE-C19 is an investigational therapy in which a patient's T-cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies. In addition to the EMA Priority Medicines Designation, the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to KTE-C19 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).
| Study | Phase | Indication | Status | |||
|
ZUMA-1 NCT02348216 |
Phase 2 Pivotal (N=112) |
Refractory DLBCL, PMBCL, TFL | Phase 2 enrolling | |||
|
ZUMA-2 NCT02601313 |
Phase 2 Pivotal (N=70) |
Relapsed/refractory MCL | Phase 2 enrolling | |||
|
ZUMA-3 NCT02614066 |
Phase 1/2 Pivotal (N=75) |
Relapsed/refractory Adult ALL | Phase 1/2 enrolling | |||
|
ZUMA-4 NCT02625480 |
Phase 1/2 Pivotal (N=75) |
Relapsed/refractory Pediatric ALL | Phase 1/2 enrolling | |||
| DLBCL = diffuse large B-cell lymphoma | ||||||
| PMBCL = primary mediastinal B-cell lymphoma | ||||||
| TFL = transformed follicular lymphoma | ||||||
| MCL = mantle cell lymphoma | ||||||
| ALL = acute lymphoblastic leukemia | ||||||
About Kite Pharma
Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a primary focus on engineered autologous cell therapy (eACT™) designed to restore the immune system's ability to recognize and eradicate tumors. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to advance multiple clinical trials of KTE-C19, and to obtain regulatory approval based on the studies of KTE-C19. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in Kite's Quarterly Report on Form 10-Q filed with the SEC on May 9, 2016. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
