Kite Pharma Initiates Rolling Submission of U.S. Biologics License Application (BLA) for KTE-C19, its Investigational anti-CD...
December 04 2016 - 10:30PM
Business Wire
•First CAR-T Therapy BLA Filing Initiated with
the U.S. Food and Drug Administration
•Company Expects to Complete BLA Submission by
the end of Q1 2017
•United States Adopted Name, or USAN, for
KTE-C19 will be axicabtagene ciloleucel
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 release.
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version on businesswire.com: http://www.businesswire.com/news/home/20161204005081/en/
Kite PharmaChristine CassianoSVP, Corporate Communications &
Investor Relationsccassiano@kitepharma.comorGreg MannVP, Investor
Relationsgmann@kitepharma.com
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