Kite, a Gilead Company (Nasdaq: GILD), today announced plans for
a new 67,000-square-foot facility in Oceanside, California,
dedicated to the development and manufacturing of viral vectors, a
critical starting material in the production of cell therapies. The
new site builds on Kite’s existing state-of-the-art manufacturing
capabilities to deliver innovative cell therapies for people with
cancer, including Yescarta® (axicabtagene ciloleucel), Kite’s first
commercially available chimeric antigen receptor T (CAR T) cell
therapy, and investigational T cell receptor (TCR) and tumor
neoantigen targeting cell therapies being evaluated in solid
tumors.
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“The new viral vector facility in Oceanside is an example of our
continued investment in achieving technical advances that will help
meet the needs of people living with cancer today and in the
future,” said Tim Moore, Executive Vice President of Technical
Operations at Kite. “Viral vectors are one of the key components in
cell therapy production, however, the industry’s current
development and manufacturing capabilities are not widely
established and supply is limited. By pursuing our own viral vector
facility, we will be able to advance viral vector development and
supply to allow for accelerated process development of current CAR
T and future pipeline therapies, while continuing to partner with
external suppliers.”
Kite’s facility will be constructed within an existing Gilead
biologics operations facility in Oceanside and will become part of
Kite’s growing commercial manufacturing network that includes sites
in California, Maryland and the Netherlands.
Important Safety Information and
Indication 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): CRS
occurred in 94% of patients, including 13% with ≥ 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 infusion
of Yescarta. Monitor patients at least daily for 7 days at the
certified healthcare facility following infusion for signs and
symptoms of CRS. Monitor patients for signs or symptoms of CRS for
4 weeks after infusion. 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: Neurologic toxicities
occurred in 87% of patients. Ninety-eight percent of all neurologic
toxicities 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 or higher 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 occurred with Yescarta.
Fatal and serious cases of cerebral edema have occurred in patients
treated with Yescarta. Monitor patients at least daily for 7 days
at the certified healthcare facility following infusion for signs
and symptoms of neurologic toxicities. Monitor patients for signs
or symptoms of neurologic toxicities for 4 weeks after infusion and
treat promptly.
YESCARTA REMS: Because of the risk of CRS and neurologic
toxicities, Yescarta is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
Yescarta REMS. The required components of the Yescarta REMS are:
Healthcare facilities that dispense and administer Yescarta must be
enrolled and comply with the REMS requirements. Certified
healthcare facilities must have on-site, immediate access to
tocilizumab, and ensure that a minimum of 2 doses of tocilizumab
are available 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 may occur. Serious hypersensitivity reactions including
anaphylaxis may be due to dimethyl sulfoxide (DMSO) or residual
gentamicin in Yescarta.
SERIOUS INFECTIONS: Severe or
life-threatening infections occurred. Infections (all grades)
occurred in 38% of patients, and in 23% with ≥ Grade 3. Grade 3 or
higher infections with 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 Yescarta 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 or higher 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 Yescarta infusion.
HYPOGAMMAGLOBULINEMIA: B-cell aplasia and
hypogammaglobulinemia 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: Patients may develop
secondary malignancies. Monitor life-long for secondary
malignancies. In the event that a secondary malignancy 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 adverse
reactions (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.
INDICATION
Yescarta is a CD19-directed genetically modified autologous T
cell immunotherapy indicated 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, high grade B-cell lymphoma, and DLBCL arising from
follicular lymphoma.
Limitation of Use: Yescarta is not indicated for the treatment
of patients with primary central nervous system lymphoma.
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 the risk that Kite may not realize the potential benefits
of this new manufacturing facility and the risk that this new
facility may not be fully operational in the currently anticipated
timelines. 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 Annual Report on Form 10-Q for the
quarter ended March 31, 2019, 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.
US Prescribing Information for Yescarta,
including BOXED WARNING and Medication Guide, is available
at www.kitepharma.com and www.gilead.com.
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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version on businesswire.com: https://www.businesswire.com/news/home/20190716005214/en/
Sung Lee, Investors (650) 524-7792
Shant Salakian, Media (424) 384-1841
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