-- Amsterdam Facility will Bring Kite’s
Potentially Life-Saving Individualized Treatment Closer to People
with Advanced Blood Cancers in the European Region --
Kite, a Gilead Company (Nasdaq: GILD), today announced it has
received approval to implement a variation to the Yescarta®
(axicabtagene ciloleucel) Marketing Authorization from the European
Medicine Agency (EMA) for end-to-end manufacturing. With this
approval, Kite’s European manufacturing facility, designed and
dedicated to the manufacture of individualized cell therapies, is
now fully operational.
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Kite’s European cell therapy
manufacturing facility, located outside of Amsterdam. (Photo:
Business Wire)
“Kite is focused foremost on the needs of patients living with
cancer and we are proud to now manufacture cell therapy directly in
Europe,” said Christi Shaw, Chief Executive Officer of Kite. “This
facility will benefit both patients and healthcare professionals,
allowing Yescarta to reach European treatment centers more quickly
and reducing the time it takes to reach patients by almost a
week.”
Kite has nearly 90 qualified treatment centers in 16 countries
across Europe and Israel. The new European facility sits next to
one of Europe’s largest airports, Amsterdam Airport Schiphol. This
central location, with its transport links to the region, will
reduce the delivery time to and from treatment centers. The
facility has the capacity to produce therapy for up to 4,000
patients per year.
“With the enhanced technology and processes at our new facility
we are pleased to be leading the next chapter in the manufacture
and delivery of CAR T therapy,” said Charles Calderaro, Kite’s
Global Head of Technical Operations. “Our new European
manufacturing facility is dedicated to cutting-edge cell
engineering, enabling patients to receive their potentially
life-saving treatment more quickly.”
“The prognosis for patients with refractory large B-cell
lymphoma is poor, with a median survival of approximately six
months with the prior standard of care,” said Marie José Kersten,
MD, PhD, Amsterdam University Medical Centers, Amsterdam, the
Netherlands. “Timely access to cell therapy is critical, and the
ability to manufacture CAR T cell therapies in Europe is welcomed
by the clinical community.”
About Kite’s Cell Therapy Manufacturing
Network
As the leader in engineered cell therapy, Kite has set a
standard with an integrated state-of-the-art global manufacturing
network that includes commercial manufacturing facilities in El
Segundo, California and Amsterdam, and clinical manufacturing in
Santa Monica, California and Gaithersburg, Maryland. Kite is also
building a third commercial cell therapy manufacturing facility in
Frederick County, Maryland, which will significantly expand the
company’s ability to manufacture CAR T cell therapies. In addition
to producing novel CAR T cell therapies, the clinical manufacturing
network is also producing investigational T cell receptor therapies
for evaluation in solid tumors. A new facility in Oceanside,
California is also under construction and will be dedicated to the
development and manufacturing of viral vectors, a critical starting
material in the production of cell therapies.
About Yescarta® (axicabtagene
ciloleucel)
Yescarta was the first CAR T cell therapy to be approved by the
U.S. Food and Drug Administration (FDA) for the treatment of adult
patients with relapsed or refractory large B-cell lymphoma after
two or more lines of systemic therapy, including diffuse large
B-cell lymphoma (DLBCL) not otherwise specified, primary
mediastinal large B-cell lymphoma, and high grade B-cell lymphoma
and DLBCL arising from follicular lymphoma. Yescarta is not
indicated for the treatment of patients with primary central
nervous system lymphoma. The Yescarta U.S. Prescribing Information
has a BOXED WARNING for the risks of cytokine release syndrome
(CRS) and neurologic toxicities, and Yescarta is approved with a
risk evaluation and mitigation strategy (REMS) due to these risks;
see below for Important Safety Information.
Yescarta is also approved in the European Union 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.
U.S. Important Safety Information for
Yescarta
BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC
TOXICITIES
- Cytokine Release Syndrome (CRS), including fatal or
life-threatening reactions, occurred in patients receiving
Yescarta. Do not administer Yescarta to patients with active
infection or inflammatory disorders. Treat severe or
life-threatening CRS with tocilizumab or tocilizumab and
corticosteroids.
- Neurologic toxicities, including fatal or life-threatening
reactions, occurred in patients receiving Yescarta, including
concurrently with CRS or after CRS resolution. Monitor for
neurologic toxicities after treatment with Yescarta. Provide
supportive care and/or corticosteroids as needed.
- Yescarta is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
Yescarta REMS.
CYTOKINE RELEASE SYNDROME (CRS) occurred in 94% of
patients, with 13% ≥ Grade 3. Among patients who died after
receiving Yescarta, 4 had ongoing CRS at death. The median time to
onset was 2 days (range: 1-12 days) and median duration was 7 days
(range: 2-58 days). Key manifestations include fever (78%),
hypotension (41%), tachycardia (28%), hypoxia (22%), and chills
(20%). Serious events that may be associated with CRS include
cardiac arrhythmias (including atrial fibrillation and ventricular
tachycardia), cardiac arrest, cardiac failure, renal insufficiency,
capillary leak syndrome, hypotension, hypoxia, and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome. Ensure that 2
doses of tocilizumab are available prior to Yescarta infusion.
Following infusion, monitor patients for signs and symptoms of CRS
at least daily for 7 days at the certified healthcare facility, and
for 4 weeks thereafter. Counsel patients to seek immediate medical
attention should signs or symptoms of CRS occur at any time. At the
first sign of CRS, institute treatment with supportive care,
tocilizumab or tocilizumab and corticosteroids as indicated.
NEUROLOGIC TOXICITIES occurred in 87% of patients, 98% of
which occurred within the first 8 weeks with a median time to onset
of 4 days (range: 1-43 days) and a median duration of 17 days.
Grade ≥3 occurred in 31% of patients. The most common neurologic
toxicities included encephalopathy (57%), headache (44%), tremor
(31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia
(9%), and anxiety (9%). Prolonged encephalopathy lasting up to 173
days was noted. Serious events including leukoencephalopathy and
seizures, as well as fatal and serious cases of cerebral edema have
occurred. Following Yescarta infusion, monitor patients for signs
and symptoms of neurologic toxicities at least daily for 7 days at
the certified healthcare facility, and for 4 weeks thereafter, and
treat promptly.
REMS: Because of the risk of CRS and neurologic
toxicities, Yescarta is available only through a restricted program
called the Yescarta REMS which requires that: Healthcare facilities
that dispense and administer Yescarta must be enrolled and comply
with the REMS requirements and must have on-site, immediate access
to a minimum of 2 doses of tocilizumab for each patient for
infusion within 2 hours after Yescarta infusion, if needed for
treatment of CRS. Certified healthcare facilities must ensure that
healthcare providers who prescribe, dispense, or administer
Yescarta are trained about the management of CRS and neurologic
toxicities. Further information is available at
www.YESCARTAREMS.com or 1-844-454-KITE (5483).
HYPERSENSITIVITY REACTIONS: Allergic reactions, including
serious hypersensitivity reactions or anaphylaxis, may occur with
the infusion of Yescarta.
SERIOUS INFECTIONS: Severe or life-threatening infections
occurred. Infections (all grades) occurred in 38% of patients.
Grade ≥3 infections occurred in 23% of patients; those due to an
unspecified pathogen occurred in 16% of patients, bacterial
infections in 9%, and viral infections in 4%. Yescarta should not
be administered to patients with clinically significant active
systemic infections. Monitor patients for signs and symptoms of
infection before and after infusion and treat appropriately.
Administer prophylactic anti-microbials according to local
guidelines. Febrile neutropenia was observed in 36% of patients and
may be concurrent with CRS. In the event of febrile neutropenia,
evaluate for infection and manage with broad spectrum antibiotics,
fluids, and other supportive care as medically indicated. Hepatitis
B virus (HBV) reactivation, in some cases resulting in fulminant
hepatitis, hepatic failure, and death, can occur in patients
treated with drugs directed against B cells. Perform screening for
HBV, HCV, and HIV in accordance with clinical guidelines before
collection of cells for manufacturing.
PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for
several weeks following lymphodepleting chemotherapy and Yescarta
infusion. Grade ≥3 cytopenias not resolved by Day 30 following
Yescarta infusion occurred in 28% of patients and included
thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor
blood counts after infusion.
HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur.
Hypogammaglobulinemia occurred in 15% of patients. Monitor
immunoglobulin levels after treatment and manage using infection
precautions, antibiotic prophylaxis, and immunoglobulin
replacement. The safety of immunization with live viral vaccines
during or following Yescarta treatment has not been studied.
Vaccination with live virus vaccines is not recommended for at
least 6 weeks prior to the start of lymphodepleting chemotherapy,
during Yescarta treatment, and until immune recovery following
treatment.
SECONDARY MALIGNANCIES may develop. Monitor life-long for
secondary malignancies. In the event that one occurs, contact Kite
at 1-844-454-KITE (5483) to obtain instructions on patient samples
to collect for testing.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the
potential for neurologic events, including altered mental status or
seizures, patients are at risk for altered or decreased
consciousness or coordination in the 8 weeks following Yescarta
infusion. Advise patients to refrain from driving and engaging in
hazardous occupations or activities, such as operating heavy or
potentially dangerous machinery, during this initial period.
ADVERSE REACTIONS: The most common (incidence ≥20%)
include CRS, fever, hypotension, encephalopathy, tachycardia,
fatigue, headache, decreased appetite, chills, diarrhea, febrile
neutropenia, infections-pathogen unspecified, nausea, hypoxia,
tremor, cough, vomiting, dizziness, constipation, and cardiac
arrhythmias.
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
Statement
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 Kite’s ability to timely manufacture and deliver CAR T
cell therapy to patients in Europe. 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, 2020, 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.
U.S. Prescribing Information for Yescarta,
including BOXED WARNING, is available at www.kitepharma.com
and www.gilead.com.
Full European Summary of Product
Characteristics for Yescarta® is available from the EMA website at
www.ema.europa.eu.
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 or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social
media on Twitter (@KitePharma) and LinkedIn.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200612005018/en/
Douglas Maffei, PhD, Investors (650) 522-2739
Nathan Kaiser, Media (650) 522-1853
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