Kite Receives U.S. Food and Drug Administration Priority Review for Axicabtagene Ciloleucel
May 26 2017 - 10:47AM
Business Wire
- First Investigational CAR-T Therapy to
Demonstrate Positive Data in Aggressive Non-Hodgkin Lymphoma
(NHL)
- Biologics License Application
Submission Based on the Primary Analysis of the ZUMA-1 Phase 2
Trial
- Prescription Drug User Fee Act (PDUFA)
Set for November 29, 2017
Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy
company, today announced that the U.S. Food and Drug Administration
(FDA) has accepted for priority review the Biologics License
Application (BLA) for axicabtagene ciloleucel. The submission
follows positive data demonstrated with a single infusion of
axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients
with refractory aggressive non-Hodgkin lymphoma (NHL). The FDA has
set a Prescription Drug User Fee Act (PDUFA) target action date of
November 29, 2017.
“Patients with refractory aggressive NHL face a dire prognosis
with only a 50 percent chance of surviving six months. This
underscores the urgent medical need for these patients and why
every day matters, from development to manufacturing to clinical
experience,” said David Chang, M.D., Ph.D., Executive Vice
President of Research and Development and Chief Medical Officer of
Kite. “We firmly believe in the potential for axicabtagene
ciloleucel to address this need and forge a new path for the future
of cell therapy.”
The filing acceptance is supported by data from the ZUMA-1 Phase
2 trial which met the primary endpoint of objective response rate
(ORR) recorded after a single infusion of axicabtagene ciloleucel
with 82 percent (p<0.0001). At a median follow-up of 8.7 months,
44 percent of patients were in ongoing response, which included 39
percent of patients in complete response (CR).
The most common grade 3 or higher adverse events included anemia
(43 percent), neutropenia (39 percent), decreased neutrophil count
(32 percent), febrile neutropenia (31 percent), decreased white
blood cell count (29 percent), thrombocytopenia (24 percent),
encephalopathy (21 percent) and decreased lymphocyte count (20
percent). There were three deaths throughout the course of the
registrational trial not due to disease progression, of which two
events, were deemed related to axicabtagene ciloleucel.
In December 2015, axicabtagene ciloleucel received Breakthrough
Therapy Designation (BTD) by the U.S. Food and Drug Administration
(FDA) for DLBCL, TFL, and PMBCL. The company expects to submit its
Market Authorization Application (MAA) of axicabtagene ciloleucel
with the European Medicines Agency (EMA) in the third quarter of
2017.
ZUMA-1 is supported in part by funding from The Leukemia &
Lymphoma Society (LLS) Therapy Acceleration Program®.
About axicabtagene ciloleucel
Kite’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
Kite is a biopharmaceutical company engaged in the development
of innovative cancer immunotherapies with a goal of providing
rapid, long-term durable response and eliminating the burden of
chronic care. The company is focused on chimeric antigen receptor
(CAR) and T cell receptor (TCR) engineered cell therapies designed
to empower the immune system's ability to recognize and kill
tumors. Kite is based in Santa Monica, CA. For more
information on Kite, 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 potential of axicabtagene ciloleucel, and
the ability and timing of submitting an MAA to the EMA for
axicabtagene ciloleucel. 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 March 31, 2017. 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/20170526005397/en/
Kite Pharma, Inc.Christine CassianoSVP, Corporate Communications
& Investor Relationsccassiano@kitepharma.comorGreg MannVP,
Investor Relationsgmann@kitepharma.com
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