Kite, a Gilead Company (Nasdaq: GILD), today announced plans for a new
facility in Frederick County, Maryland, which will produce innovative
cell therapies for people with cancer. The 20-acre site will
significantly expand Kite’s ability to manufacture a variety of chimeric
antigen receptor T (CAR T) therapies, including Yescarta®
(axicabtagene ciloleucel), Kite’s first commercially available CAR T
cancer therapy, and investigational T cell receptor (TCR) cell therapies
being evaluated in solid tumors.
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“This new facility in Frederick County builds on our substantial
technical capabilities and rapid progress in making personalized CAR T
and TCR cell therapies for people with cancer. As we advance our
industry-leading cell therapy pipeline and seek to help a growing number
of people with cancer, expanding and investing in our manufacturing
capabilities is essential,” said Tim Moore, Executive Vice President of
Technical Operations at Kite. “With the Frederick County site, we will
have the opportunity to build and design the facility tailored to our
own innovative processes and with state-of-the-art features that will
enable us to meet the future needs for cell therapies.”
CAR T therapies require many complex and carefully controlled,
multi-step processes. The Frederick County facility will become part of
Kite’s growing commercial manufacturing network that includes sites in
California 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-K for the
year ended December 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.
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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