June 29, 2018
European CHMP Adopts Positive Opinion for Yescarta® (axicabtagene ciloleucel) for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy
FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)--Jun. 29, 2018--
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European
Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use
(CHMP) has issued a positive opinion on the company’s Marketing
Authorization Application (MAA) for Yescarta® (axicabtagene
ciloleucel) as a treatment for adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal
large B-cell lymphoma (PMBCL), after two or more lines of systemic
therapy.
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Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T)
therapy that modifies a patient’s own T cells to recognize and attack
cancer cells and has the potential to induce complete responses (no
detectable cancer) in a proportion of patients with aggressive forms of
non-Hodgkin lymphoma (NHL). Axicabtagene ciloleucel was granted PRIME
status by the EMA in May 2016.
The CHMP positive opinion was adopted following review by European Union
(EU) regulators, including the Committee for Advanced Therapies and the
CHMP. The recommendation will now be reviewed by the European Commission
(EC), which has the authority to approve medicines for use in the 28
countries of the EU, Norway, Iceland and Liechtenstein.
“This CHMP positive opinion is an important milestone for those patients
in the European Union living with DLBCL or PMBCL,” said Alessandro Riva,
MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head,
Cell Therapy. “The recommendation brings axicabtagene ciloleucel one
step closer to adult patients who currently have few or no treatment
options available to them and we are focused on providing access to this
innovative treatment as quickly as possible.”
The MAA is supported by data from the ZUMA-1 trial of axicabtagene
ciloleucel in adult patients with refractory aggressive NHL. In the
single-arm trial, 72 percent of patients (n=73/101) who received a
single infusion of axicabtagene ciloleucel responded to therapy with 51
percent (n=52/101) achieving a complete response (as assessed by an
independent review committee, median follow up of 15.1 months). Grade 3
or higher adverse events reported during ZUMA-1 included, but were not
restricted to, cytokine release syndrome (CRS), neurologic events and
cytopenias.
DLBCL is the most common form of NHL and represents an area of
significant unmet need. The prognosis for patients with refractory DLBCL
is very poor, with a median survival of just six months. Across the EU
in 2018, there are an estimated 7,700 patients with DLBCL who are
refractory to, or have relapsed after, two or more lines of therapy, and
may be eligible for CAR T therapy.
Axicabtagene ciloleucel was approved by the U.S. Food and Drug
Administration on October 18, 2017. In the EU, axicabtagene ciloleucel
is an investigational product and its efficacy and safety have not been
established.
About Kite
Kite, a Gilead Company, is a biopharmaceutical company based in Santa
Monica, California. Kite is engaged in the development of innovative
cancer immunotherapies. The company is focused on chimeric antigen
receptor and T cell receptor engineered cell therapies. For more
information on Kite, please visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead Sciences,
please visit the company’s website at www.gilead.com.
Forward-Looking Statements
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that the European Commission may not approve axicabtagene ciloleucel in
the currently anticipated timelines or at all, and any marketing
approval, if granted, may have significant limitations on its use. All
statements other than statements of historical fact are statements that
could be deemed forward-looking statements. These risks, uncertainties
and other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These and
other risks are described in detail in Gilead’s Quarterly Report on Form
10-Q for the quarter ended March 31, 2018, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements are
based on information currently available to Gilead and Kite, and Gilead
and Kite assume no obligation to update any such forward-looking
statements.
Yescarta is a registered trademark of Gilead Sciences, Inc., or its
related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com.
Learn more about Gilead at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
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