Kite Pharma Surges as FDA Grants Breakthrough Tag for Lymphoma Drug
Published: Dec 07, 2015
SANTA MONICA, Calif., Dec. 7, 2015 (GLOBE NEWSWIRE) -- Kite Pharma, Inc. (Nasdaq:KITE) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company's lead product candidate, 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 is an investigational therapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias.
"The FDA's designation of KTE-C19 as a breakthrough therapy recognizes the potential for KTE-C19 to address the unmet need for patients with refractory DLBCL, PMBCL, and TFL," noted Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "We are pleased to receive this designation and look forward to working more closely with the FDA as we continue to advance our program for KTE-C19."
Breakthrough Therapy Designation is granted by the FDA to expedite the development and review of new therapies to treat serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the therapy may have substantial improvement on at least one clinically significant endpoint over available therapy. This designation conveys all fast track program features, as well as more intensive FDA guidance on an efficient drug development program and eligibility for rolling review and priority review.
About Kite's ZUMA Clinical Programs
|ZUMA-1||Phase 2 Pivotal||Refractory DLBCL, PMBCL, TFL||Phase 2 enrolling|
|ZUMA-2||Phase 2 Pivotal||Relapsed/refractory MCL||Phase 2 enrolling|
|ZUMA-3||Phase 1/2 Pivotal||Relapsed/refractory Adult ALL||Phase 1/2 enrolling|
|ZUMA-4||Phase 1/2 Pivotal||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 its Form 10-Q for the quarter ended September 30, 2015. 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.
CONTACT: Kite Pharma Cynthia M. Butitta Chief Financial Officer and Chief Operating Officer 310-824-9999 For Media: Justin Jackson For Investor Inquiries: Lisa Burns Burns McClellan 212-213-0006 firstname.lastname@example.org email@example.com