•First CAR-T Therapy BLA Filing Initiated with the U.S. Food and Drug
•Company Expects to Complete BLA Submission by the end of Q1 2017
•United States Adopted Name, or USAN, for KTE-C19 will be axicabtagene
SANTA MONICA, Calif.--(BUSINESS WIRE)--
Kite Pharma, Inc. (Nasdaq:KITE)
today announced that it has initiated the rolling submission with the
U.S. Food and Drug Administration (FDA) of the Biologics License
Application (BLA) for KTE-C19 as a treatment for patients with
relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are
ineligible for autologous stem cell transplant (ASCT). The pivotal
ZUMA-1 study supporting this submission enrolled patients with
chemorefractory diffuse large B-cell lymphoma (DLBCL), transformed
follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma
(PMBCL), three subtypes of aggressive NHL. The company expects to
complete its BLA submission by the end of the first quarter of 2017.
"I am both proud and appreciative of the Kite team and our clinical
investigators, who have helped to make this key milestone possible,"
said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief
Executive Officer of Kite. "This is an important first step toward
Kite's biggest goal - bringing to market a potentially life-saving
treatment for patients suffering from aggressive NHL."
Kite also announced that the United States Adopted Name, or USAN, for
KTE-C19 will be axicabtagene ciloleucel.
Axicabtagene ciloleucel (KTE-C19) received Breakthrough Therapy
Designation (BTD) by the FDA in December 2015. If approved, Kite plans
to commercially launch KTE-C19 in 2017. Kite is also planning a
regulatory submission to the European Medicines Agency (EMA) for
axicabtagene ciloleucel in 2017. Kite was granted access to Priority
Medicines (PRIME) regulatory support in 2016 by the EMA for axicabtagene
ciloleucel (KTE-C19) for the treatment of refractory DLBCL.
About axicabtagene ciloleucel
Kite Pharma's lead product candidate, axicabtagene ciloleucel, is an
investigational therapy in which a patient's T cells are engineered to
express a chimeric antigen receptor (CAR) to target the antigen CD19, a
protein expressed on the cell surface of B-cell lymphomas and leukemias,
and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel
has been granted Breakthrough Therapy Designation status for diffuse
large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL),
and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and
Drug Administration (FDA) and Priority Medicines (PRIME) regulatory
support for DLBCL in the EU.
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. The press release 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 intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the ability and
timing of obtaining axicabtagene ciloleucel (KTE-C19) data, completing a
BLA submission with the FDA, obtaining regulatory approval, commercially
launching axicabtagene ciloleucel, and seeking marketing approval with
the EMA. 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, 2016.
Any forward-looking statements that are made in this press release speak
only as of the date of this press release. Kite assumes no obligation to
update the forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this press
View source version on businesswire.com: http://www.businesswire.com/news/home/20161204005081/en/
SVP, Corporate Communications &
VP, Investor Relations
Source: Kite Pharma, Inc.
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