THOUSAND OAKS, Calif.,
Sept. 24, 2018 /PRNewswire/
-- Amgen (NASDAQ:AMGN) today announced that the Japanese
Ministry of Health, Labour and Welfare has granted marketing
approval for BLINCYTO® (blinatumomab) for the
treatment of relapsed or refractory B-cell acute lymphoblastic
leukemia (ALL). BLINCYTO was developed in Japan by Amgen Astellas BioPharma K.K. (AABP),
a joint venture between Amgen and Astellas Pharma Inc., a
pharmaceutical company headquartered in Tokyo.
"As proof-of-concept for our bispecific T cell engager
technology, BLINCYTO has laid the groundwork for Amgen to deliver
on our passion of addressing cancer by exploring numerous biologic
pathways and therapeutic modalities," said David M. Reese, M.D., executive vice president
of Research and Development at Amgen. "This innovation is a good
example of how we provide new options to patients with serious
illnesses like cancer. In bringing BLINCYTO to Japanese patients,
we reinforce our commitment to deliver novel cancer therapies on
behalf of patients worldwide."
BLINCYTO is the first-and-only bispecific T cell engager
(BiTE®) immunotherapy construct approved globally. It is
also the first approved immunotherapy from Amgen's BiTE®
platform, an innovative approach that helps the body's immune
system target cancer cells.
"Today's approval of BLINCYTO marks a significant milestone that
reinforces our commitment to addressing unmet medical needs of
patients in Japan," said
Steve Sugino, president and
representative director, AABP. "As our first oncology treatment
approved in the region, we are proud to provide a much-needed
innovative treatment option for adults and children with relapsed
or refractory B-cell ALL, one of the most aggressive B-cell
malignancies."
Hitoshi Kiyoi, M.D., Ph.D.,
professor of internal medicine, Hematology and Oncology, Nagoya
University Graduate School of Medicine said, "The standard therapy
for relapsed or refractory B-cell ALL has not been established in
Japan and therefore different
chemotherapy regimens have been selected, depending on the
condition and background of each patient. BLINCYTO is a much-needed
and important new treatment option for patients with relapsed or
refractory B-cell ALL, as demonstrated by the efficacy and survival
benefit seen in the TOWER study."
The approval is based on data from multiple global studies,
including the Phase 3 TOWER study and Japan Phase 1b/2 Horai study. In the TOWER study, BLINCYTO
demonstrated a superior improvement in median overall survival (OS)
versus standard of care (SOC) chemotherapy. Median OS was 7.7
months (95 percent CI: 5.6, 9.6) for BLINCYTO versus 4.0 months (95
percent CI: 2.9, 5.3) for SOC (HR for
death=0.71; p=0.012). Safety results among subjects who
received BLINCYTO were comparable to those seen in the previous
Phase 2 studies of BLINCYTO in adult patients with Philadelphia chromosome-negative (Ph-)
relapsed or refractory B-cell precursor ALL. In the TOWER study,
major adverse reactions were pyrexia (39.0 percent), decrease in
white blood cell count (14.6 percent), cytokine release syndrome
(13.5 percent), febrile neutropenia (10.9 percent), headache (10.1
percent), elevated liver enzyme (10.1 percent) and decrease in
platelet count (10.1 percent). In the Phase 1b/2 Horai study, BLINCYTO was administered to 35
Japanese adult and pediatric patients with relapsed or refractory
B-cell precursor ALL. The safety results from the Horai study were
comparable to those seen in the global studies, including TOWER. In
the Horai study, major adverse reactions in adult patients were
cytokine release syndrome (46.2 percent), pyrexia (46.2 percent),
decrease in white blood cell count (38.5 percent) and decrease in
platelet count (34.6 percent), and major adverse reactions in
pediatric patients were elevated liver enzyme (66.7 percent),
pyrexia (66.7 percent), cytokine release syndrome (55.6 percent)
and abdominal pain (44.4 percent).
BLINCYTO is now approved in 57 countries, including the United States (U.S.), all member countries
in the European Union (EU) and the European Economic Area,
Canada and Australia.
About the TOWER Study
The TOWER study was a Phase 3,
randomized, active-controlled, open-label study investigating the
efficacy of BLINCYTO versus SOC chemotherapy in 405 adult patients
with Ph- relapsed or refractory B-cell precursor ALL. The study
enrolled a difficult-to-treat patient population which included
patients with one or more relapses or refractory disease. In the
BLINCYTO arm, this included 35 percent of patients that had
relapsed post-allogenic hematopoietic stem cell transplant
(alloHSCT) and excluded those with late first relapse (≥12 months
after initial remission). Patients were randomized in a 2:1 ratio
to receive BLINCYTO (n=271) or treatment with investigator choice
of SOC chemotherapy (n=134). The determination of efficacy was
based on OS. These results were published in The New England
Journal of Medicine.1
About the Horai Study
The Horai study is a Phase
1b/2, single-arm, open-label study
evaluating the safety and efficacy of BLINCYTO in Japanese adult
and pediatric patients with relapsed or refractory B-cell precursor
ALL. The primary endpoint for the Phase 1b portion was incidence of dose-limiting
toxicities; the primary endpoint for the Phase 2 portion was
complete remission or complete remission with partial hematologic
recovery within 12 weeks of treatment with BLINCYTO. Secondary
endpoints include duration of response, OS and relapse-free
survival. An extension of the study is ongoing. For more
information about this trial, please visit www.clinicaltrials.gov
under trial identification number NCT02412306.
About ALL in Japan
ALL is a rapidly progressing
cancer of the blood and bone marrow that occurs in both adults and
children.2,3 Japan is
reported to have approximately 5,000 ALL patients, and it is
estimated that of these, there are around 520 patients with
relapsed or refractory ALL annually.4-7 Adults with
relapsed or refractory ALL typically have a very poor prognosis,
with a median OS of three to five months.8 Prognosis for
children with ALL who are refractory or experience a relapse is
extremely poor, and post-relapse survival is only achieved in 40-50
percent of patients.9-11
About
BiTE® Technology
Bispecific T cell
engager (BiTE®) antibody constructs are a novel
immune-oncology technology that can be engineered to target any
tumor antigen expressed by any type of cancer. The modified
antibodies are designed to kill malignant cells using the patient's
own immune system by bridging T cells to tumor cells.
BiTE® antibody constructs help connect the T cells
to the targeted cell, with the intent of causing T cells to inject
toxins which trigger cancer cell death (apoptosis). Amgen is
developing BiTE® antibody constructs to uniquely
(or specifically) target numerous hematologic malignancies and
solid tumors.
About
BLINCYTO® (blinatumomab)
BLINCYTO is
a bispecific CD19-directed CD3 T cell engager (BiTE®)
immunotherapy that binds to CD19 expressed on the surface of cells
of B-lineage origin and CD3 expressed on the surface of effector T
cells. BLINCYTO was granted breakthrough therapy and priority
review designations by the U.S. Food and Drug Administration
(FDA) in 2014, and now carries full approval in the U.S. for the
treatment of relapsed or refractory B-cell precursor ALL in
adults and children. In the U.S., BLINCYTO is also approved under
accelerated approval for the treatment of adults and children with
B-cell precursor ALL in first or second complete remission with
minimal residual disease (MRD) greater than or equal to 0.1
percent.
BLINCYTO is approved in the EU for the treatment of
Ph- relapsed or refractory B-cell precursor ALL in adults and
children.
Important Japan Product Information
Indication:
Relapsed or refractory B-cell acute
lymphoblastic leukemia
Dosage and Administration:
In general, blinatumomab
(Genetical Recombination) is administered as continuous intravenous
infusion with the following dosing regimen for 28 days followed by
a 14-day treatment-free interval. This constitutes one cycle and is
repeated up to 5 cycles. After that, blinatumomab (Genetical
Recombination) is administered with the following dosing regimen
for 28 days followed by a 56-day treatment-free interval. This
constitutes one cycle and is repeated up to 4 cycles. Of note, dose
of BLINCYTO® can be reduced as appropriate depending on
patient's condition.
- Patients with a body weight of ≥45 kg: 9 μg/day on Days 1 to 7
of Cycle 1, then 28 μg/day.
- Patients with a body weight of <45 kg: 5 μg/m2
(body surface area [BSA])/day on Days 1 to 7 of Cycle 1, then 15
μg/m2 (BSA)/day. The dose should not exceed the dose for
patients with a body weight of ≥45 kg.
For more information, see the latest Japan Package Inserts.
Important Safety Information Regarding BLINCYTO®
(blinatumomab) U.S. Indication
BLINCYTO is indicated for the
treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in
first or second complete remission with minimal residual disease
(MRD) greater than or equal to 0.1% in adults and children. This
indication is approved under accelerated approval based on MRD
response rate and hematological relapse-free survival. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in the confirmatory trials.
BLINCYTO is indicated for the treatment of relapsed or
refractory B-cell precursor acute lymphoblastic leukemia (ALL) in
adults and children.
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL
TOXICITIES
- Cytokine Release Syndrome (CRS), which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue BLINCYTO®
as recommended.
- Neurological toxicities, which may be severe,
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. Interrupt or discontinue BLINCYTO®
as recommended.
Contraindications
BLINCYTO® is contraindicated in patients with a
known hypersensitivity to blinatumomab or to any component of the
product formulation.
Warnings and Precautions
- Cytokine Release Syndrome (CRS): CRS, which may be
life-threatening or fatal, occurred in patients receiving
BLINCYTO®. The median time to onset of CRS is 2 days
after the start of infusion. Closely monitor patients for signs and
symptoms of serious adverse events such as fever, headache, nausea,
asthenia, hypotension, increased alanine aminotransferase (ALT),
increased aspartate aminotransferase (AST), increased total
bilirubin (TBILI), and disseminated intravascular coagulation
(DIC). The manifestations of CRS after treatment with BLINCYTO
overlap with those of infusion reactions, capillary leak syndrome
(CLS), and hemophagocytic histiocytosis/macrophage activation
syndrome (MAS). In clinical trials of BLINCYTO, CRS was reported in
15% of patients with relapsed or refractory ALL and in 7% of
patients with MRD-positive ALL. Interrupt or discontinue
BLINCYTO® as outlined in the PI.
- Neurological Toxicities: Approximately 65% of patients
receiving BLINCYTO® in clinical trials experienced
neurological toxicities. The median time to the first event was
within the first 2 weeks of BLINCYTO® treatment and the
majority of events resolved. The most common (≥ 10%) manifestations
of neurological toxicity were headache and tremor. Severe,
life‐threatening, or fatal neurological toxicities occurred in
approximately 13% of patients, including encephalopathy,
convulsions, speech disorders, disturbances in consciousness,
confusion and disorientation, and coordination and balance
disorders. Manifestations of neurological toxicity included cranial
nerve disorders. Monitor patients for signs or symptoms and
interrupt or discontinue BLINCYTO® as outlined in the
PI.
- Infections: Approximately 25% of patients receiving
BLINCYTO® in clinical trials experienced serious
infections such as sepsis, pneumonia, bacteremia, opportunistic
infections, and catheter-site infections, some of which were
life-threatening or fatal. Administer prophylactic antibiotics and
employ surveillance testing as appropriate during treatment.
Monitor patients for signs or symptoms of infection and treat
appropriately, including interruption or discontinuation of
BLINCYTO® as needed.
- Tumor Lysis Syndrome (TLS), which may be life-threatening or
fatal, has been observed. Preventive measures, including
pretreatment nontoxic cytoreduction and on-treatment hydration,
should be used during BLINCYTO® treatment. Monitor
patients for signs and symptoms of TLS and interrupt or discontinue
BLINCYTO® as needed to manage these events.
- Neutropenia and Febrile Neutropenia, including life-threatening
cases, have been observed. Monitor appropriate laboratory
parameters (including, but not limited to, white blood cell count
and absolute neutrophil count) during BLINCYTO® infusion
and interrupt BLINCYTO® if prolonged neutropenia
occurs.
- Effects on Ability to Drive and Use Machines: Due to the
possibility of neurological events, including seizures, patients
receiving BLINCYTO® are at risk for loss of
consciousness, and should be advised against driving and engaging
in hazardous occupations or activities such as operating heavy or
potentially dangerous machinery while BLINCYTO® is being
administered.
- Elevated Liver Enzymes: Transient elevations in liver enzymes
have been associated with BLINCYTO® treatment with a
median time to onset of 3 days. In patients receiving
BLINCYTO®, although the majority of these events were
observed in the setting of CRS, some cases of elevated liver
enzymes were observed outside the setting of CRS, with a median
time to onset of 19 days. Grade 3 or greater elevations in liver
enzymes occurred in approximately 7% of patients outside the
setting of CRS and resulted in treatment discontinuation in less
than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase
(GGT), and TBILI prior to the start of and during
BLINCYTO® treatment. BLINCYTO® treatment
should be interrupted if transaminases rise to > 5 times the
upper limit of normal (ULN) or if TBILI rises to > 3 times
ULN.
- Pancreatitis: Fatal pancreatitis has been reported in patients
receiving BLINCYTO® in combination with dexamethasone in
clinical trials and the post-marketing setting. Evaluate patients
who develop signs and symptoms of pancreatitis and interrupt or
discontinue BLINCYTO® and dexamethasone as needed.
- Leukoencephalopathy: Although the clinical significance is
unknown, cranial magnetic resonance imaging (MRI) changes showing
leukoencephalopathy have been observed in patients receiving
BLINCYTO®, especially in patients previously treated
with cranial irradiation and antileukemic chemotherapy.
- Preparation and administration errors have occurred with
BLINCYTO® treatment. Follow instructions for preparation
(including admixing) and administration in the PI strictly to
minimize medication errors (including underdose and overdose).
- Immunization: Vaccination with live virus vaccines is not
recommended for at least 2 weeks prior to the start of
BLINCYTO® treatment, during treatment, and until immune
recovery following last cycle of BLINCYTO®.
- Risk of Serious Adverse Reactions in Pediatric Patients due to
Benzyl Alcohol Preservative: Serious and fatal adverse reactions
including "gasping syndrome," which is characterized by central
nervous system depression, metabolic acidosis, and gasping
respirations, can occur in neonates and infants treated with benzyl
alcohol-preserved drugs including BLINCYTO® (with
preservative). When prescribing BLINCYTO® (with
preservative) for pediatric patients, consider the combined daily
metabolic load of benzyl alcohol from all sources including
BLINCYTO® (with preservative) and other drugs containing
benzyl alcohol. The minimum amount of benzyl alcohol at which
serious adverse reactions may occur is not known. Due to the
addition of bacteriostatic saline, 7-day bags of
BLINCYTO® solution for infusion with preservative
contain benzyl alcohol and are not recommended for use in any
patients weighing < 22 kg.
Adverse Reactions
- The most common adverse reactions (≥ 20%) in clinical trial
experience of patients with MRD-positive B-cell precursor ALL
(BLAST Study) treated with BLINCYTO® were pyrexia,
infusion related reactions, headache, infections (pathogen
unspecified), tremor, and chills. Serious adverse reactions were
reported in 61% of patients. The most common serious adverse
reactions (≥2%) included pyrexia, tremor, encephalopathy, aphasia,
lymphopenia, neutropenia, overdose, device related infection,
seizure, and staphylococcal infection.
- The most common adverse reactions (≥ 20%) in clinical trial
experience of patients with Philadelphia chromosome-negative relapsed or
refractory B-cell precursor ALL (TOWER Study) treated with
BLINCYTO® were infections (bacterial and pathogen
unspecified), pyrexia, headache, infusion-related reactions,
anemia, febrile neutropenia, thrombocytopenia, and neutropenia.
Serious adverse reactions were reported in 62% of patients. The
most common serious adverse reactions (≥ 2%) included febrile
neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock,
CRS, bacterial sepsis, device related infection, and
bacteremia.
- Adverse reactions that were observed more frequently (≥ 10%) in
the pediatric population compared to the adult population were
pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs.
24%), infusion-related reaction (49% vs. 34%), thrombocytopenia
(34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17%
vs. 6%).
- In pediatric patients less than 2 years old (infants), the
incidence of neurologic toxicities was not significantly different
than for the other age groups, but its manifestations were
different; the only event terms reported were agitation, headache,
insomnia, somnolence, and irritability. Infants also had an
increased incidence of hypokalemia (50%) compared to other
pediatric age cohorts (15-20%) or adults (17%).
Dosage and Administration Guidelines
- BLINCYTO® is administered as a continuous
intravenous infusion at a constant flow rate using an infusion pump
which should be programmable, lockable, non-elastomeric, and have
an alarm.
- It is very important that the instructions for preparation
(including admixing) and administration provided in the full
Prescribing Information are strictly followed to minimize
medication errors (including underdose and overdose).
Please see full Prescribing Information, including Boxed
WARNINGS and Medication Guide, for BLINCYTO®.
About Amgen's Commitment to Oncology
Amgen
Oncology is committed to helping patients take on some of the
toughest cancers, such as those that have been resistant to drugs,
those that progress rapidly through the body and those where
limited treatment options exist. Amgen's supportive care
treatments help patients combat certain side effects of strong
chemotherapy, and our targeted medicines and immunotherapies focus
on more than a dozen different malignancies, ranging from blood
cancers to solid tumors. With decades of experience providing
therapies for cancer patients, Amgen continues to grow
its portfolio of innovative and biosimilar oncology medicines.
For more information, follow us on
www.twitter.com/amgenoncology.
About Amgen
Amgen is committed to unlocking
the potential of biology for patients suffering from serious
illnesses by discovering, developing, manufacturing and delivering
innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease
and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow
us on www.twitter.com/amgen.
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CONTACT: Amgen, Thousand
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