Market Overview

Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy


-- New Option for Adult Patients in Europe as Axicabtagene
Ciloleucel Becomes the First CAR T to Receive European Approval for Two
Types of Aggressive Non-Hodgkin Lymphoma --

Kite, a Gilead Company (NASDAQ:GILD), today announced that the European
Commission (EC) has granted Marketing Authorization 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. The Marketing Authorization approves
axicabtagene ciloleucel for use in the 28 countries of the European
Union, Norway, Iceland and Liechtenstein.

This press release features multimedia. View the full release here:

Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T)
therapy, which harnesses a patient's own immune system to fight certain
types of blood cancer. The cell therapy has been proven to induce
complete response (no detectable cancer) in a proportion of patients
with relapsed or refractory DLBCL and PMBCL, which are aggressive forms
of non-Hodgkin lymphoma (NHL).

"Axicabtagene ciloleucel is a new and exciting way of treating cancer
that offers a new option to patients with DLBCL and PMBCL in Europe,"
said Professor Gilles Salles, Head of Hematology, South Lyon Hospital
Complex. "Many patients with these aggressive forms of non-Hodgkin
lymphoma who have not responded to or failed commonly available
treatment options have a very poor prognosis and there is an urgent need
for new therapies."

The Marketing Authorization Application (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). At one year following infusion, 60
percent of patients were alive (95% CI: 50.2, 69.2) and the median
overall survival (OS) had not been reached (95% CI: not estimable [NE]).

Axicabtagene ciloleucel may cause side effects that are severe or life
threatening, such as cytokine release syndrome (CRS) or neurological
toxicities. In ZUMA-1, 12 percent of patients experienced Grade 3 or
higher CRS and 31 percent experienced Grade 3 or higher neurologic
toxicities. Overall 98 percent of patients recovered from CRS and/or
neurologic adverse reactions. Treatment algorithms have been developed
to manage some of the symptoms associated with both CRS and neurologic
adverse reactions experienced by patients on axicabtagene ciloleucel.

The most common Grade 3 or higher adverse reactions include
encephalopathy, unspecified pathogen infection, CRS, bacterial
infection, aphasia, viral infection, delirium, hypotension and

For full details on the Special Warnings and Precautions for Use and
Adverse Reactions (including appropriate management) please refer to the
EU Summary of Product Characteristics (SmPC).

"We are proud to be leading this frontier of cancer innovation that is
bringing novel, personalized therapy to people living with these blood
cancers," said Alessandro Riva, MD, Gilead's Executive Vice President,
Oncology Therapeutics & Head, Cell Therapy. "Our vision is for cell
therapy to serve as the foundation for treating all cancer types.
Today's milestone is another step on this exciting and important

Axicabtagene ciloleucel was approved by the U.S. Food and Drug
Administration on October 18, 2017.

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

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

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 physicians may not see the benefits of prescribing axicabtagene
ciloleucel for the treatment of DLBCL and PMBCL and the possibility of
unfavorable results from additional clinical trials involving
axicabtagene ciloleucel. 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
June 30, 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.

Full European Summary of Product Characteristics for Yescarta®
is available from the EMA website at

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
Learn more about Gilead at,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.

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