Orencia is the first and only FDA-approved
therapy to help prevent this serious complication that impacts
between 30-70% of hematopoietic stem cell transplant recipients1
Approval marks fourth indication for
Orencia, an established treatment across three rheumatic
diseases2
Bristol Myers Squibb (NYSE:BMY):
U.S. Food and Drug Administration Approves
Orencia® (abatacept) in Combination with a Calcineurin Inhibitor
and Methotrexate for the Prevention of Acute Graft Versus Host
Disease (aGvHD) in Patients Undergoing Hematopoietic Stem Cell
Transplant from a Matched or 1 Allele-Mismatched Unrelated
Donor
Bristol Myers Squibb (NYSE:BMY) today announced that Orencia®
(abatacept) was approved by the U.S. Food and Drug Administration
(FDA) for the prophylaxis, or prevention, of acute graft versus
host disease (aGvHD), in combination with a calcineurin inhibitor
(CNI) and methotrexate (MTX), in adults and pediatric patients 2
years of age and older undergoing hematopoietic stem cell
transplantation (HSCT) from a matched or 1 allele-mismatched
unrelated donor (URD).2
“Orencia is the first FDA-approved therapy to prevent acute
graft versus host disease following hematopoietic stem cell
transplant, a potentially life-threatening complication that can
pose a comparatively higher risk to racial and ethnic minority
populations in the U.S. due to difficulty finding appropriately
matched donors,”2,3 said Tina Deignan, senior vice president, U.S.
Immunology, Bristol Myers Squibb. “With this fourth indication for
Orencia, Bristol Myers Squibb draws on its legacy and expertise in
both immunology and hematology to deliver an important treatment
option for patients in a disease with high unmet need.”1,2
Allogeneic HSCT is a treatment for hematologic diseases that
involves the infusion of hematopoietic stem cells, which include
donor T-cells, a type of white blood cell that recognizes and
destroys foreign invaders and damaged or cancerous cells in the
recipient’s body. Acute graft versus host disease occurs when the
donor T-cells recognize the patient’s healthy cells as foreign and
start attacking healthy tissues and organs.1
Orencia – a therapy that is also currently approved to treat
adults with moderate to severe rheumatoid arthritis, active
psoriatic arthritis, and moderate to severe polyarticular juvenile
idiopathic arthritis in children 2 and older – binds to and
modulates protein targets involved in costimulation, thus
inhibiting T-cell activation.2 The relationship of these biological
response markers to the mechanisms by which Orencia exerts its
clinical effects is unknown.
The concomitant use of Orencia with other immunosuppressives
[e.g., biologic disease-modifying antirheumatic drugs (bDMARDS),
Janus kinase (JAK) inhibitors] is not recommended.2 Orencia is
associated with the following Warnings and Precautions: increased
risk of infection with concomitant use with TNF antagonists, other
biologic RA/PsA therapy, or JAK inhibitors; hypersensitivity;
increased risk of serious infections; interactions with
immunizations; increased risk of adverse events when used in
patients with chronic obstructive pulmonary disease;
immunosuppression; and cytomegalovirus (CMV) and Epstein-Barr virus
(EBV) reactivation in aGvHD prophylaxis after HSCT.2 Please see
Important Safety Information below and U.S. Full Prescribing
Information for additional details. The most common adverse events
(≥10%) in rheumatoid arthritis are headache, upper respiratory
tract infection, nasopharyngitis, and nausea. The most commonly
reported adverse reactions in the prophylaxis of aGvHD with an
incidence of at least 10% in Orencia-treated patients and at least
2% greater than placebo were anemia, hypertension, CMV
reactivation/CMV infection, pyrexia, pneumonia, epistaxis, CD4
lymphocytes decreased, hypermagnesemia, and acute kidney
injury.2
“In the GVHD-1 trial, abatacept demonstrated improved severe
(grade III-IV) aGvHD-free survival in 7/8 mismatched unrelated
donor transplant and associated mortality,”4 said Leslie Kean,
M.D., director of the Stem Cell Transplantation Center at
Dana-Farber/Boston Children's Cancer and Blood Disorders Center.
“The findings suggest abatacept could play an important role in
preventing aGvHD in hematopoietic stem cell transplant. From these
results, providers may also have more confidence in expanding the
donor pool to include unrelated matched or 1 allele-mismatched
donors for patients in need.”
This approval is based on results from the Phase 2 GVHD-1 trial,
also known as ABA2, that evaluated Orencia when added to a regimen
of a CNI (cyclosporine or tacrolimus) and MTX for prophylaxis of
aGvHD in patients undergoing HSCT, and a clinical study known as
GVHD-2 using data from the Center for International Blood and
Marrow Transplant Research (CIBMTR).2,4 GVHD-1 was a multicenter,
two cohort trial (a double-blind, placebo controlled cohort and
open-label, single-arm cohort) of patients age 6 years and older
who underwent HSCT from a matched (n=142) or 1 allele-mismatched
(n=43) URD.2 GVHD-2 – a second clinical study using data from the
CIBMTR – was also conducted to analyze outcomes of Orencia in
combination with CNI and MTX (n=54) for aGvHD prophylaxis in
comparison to that of recipients who received only CNI and MTX
(n=162), in patients 6 years of age or older undergoing HSCT from a
1 allele-mismatched URD between 2011 and 2018.2,4 Please see below
for additional trial data.
“With Orencia’s approval as a preventive option for aGvHD
following unrelated donor HSCT, we hope hematopoietic stem cell
transplant becomes a more accessible option for more patients,”2
explains Steven Devine, M.D., chief medical officer, NMDP/Be The
Match, and associate scientific director, CIBMTR®. “This may
include patients of diverse ethnicities, who often have lower
likelihoods of finding matched donors.”3
An abstract with the GVHD-2 data was presented at the American
Society of Hematology Annual Meeting and Exposition in December
2021.
The FDA’s review was conducted under its Project Orbis
initiative, which enabled concurrent and/or shared FDA review with
the health authorities in Canada, Switzerland and as a pilot in
Israel. Orencia is not approved for this indication in these
countries.
About GVHD-1 (ABA2)
The GVHD-1 study (NCT01743131), also known as ABA2– “Abatacept
Combined with a Calcineurin Inhibitor and Methotrexate for Graft
versus Host Disease Prophylaxis: A Randomized Controlled Trial” –
was a multicenter, two cohort, Phase 2 investigator sponsored trial
conducted by Dr. Leslie Kean of Dana-Farber/Boston Children’s.4 The
efficacy and safety of Orencia, in combination with a CNI and MTX,
for the prophylaxis of aGvHD was evaluated in this trial in
patients age 6 years and older who underwent HSCT from a matched or
1 allele-mismatched URD.2,4
The two cohorts in GVHD-1 were 1) an open-label, single-arm
study of patients who underwent a 7 of 8 HLA-matched HSCT (n=43)
(“7/8” cohort), and 2) a randomized (1:1), double-blind,
placebo-controlled study of patients who underwent an 8 of 8
HLA-matched HSCT who received Orencia (n=73) or placebo (n=69) in
combination with a CNI and MTX (“8/8” cohort).2 All subjects
received a CNI, with dosing starting on Day -2 and continuing
through at least Day 100 as tolerated, and MTX on Days 1, 3, 6 and
11 after transplant.4 Orencia-treated subjects received 10 mg/kg
Orencia as an intravenous (IV) infusion over 60 minutes on Day -1
(the day before transplantation), followed by Days 5, 14 and 28
after transplantation.2 In both cohorts, efficacy was established
based on overall survival (OS) and grade II-IV aGvHD-free survival
results assessed at Day 180 post-transplantation.2 Orencia + CNI
and MTX did not significantly improve grade III-IV aGvHD-free
survival versus placebo + CNI and MTX at Day 180
post-transplantation.
In the 8/8 HLA-matched cohort, an estimated rate of grade III-IV
aGvHD-free survival of 87% was observed for the Orencia IV + CNI +
MTX group versus 75% for placebo + CNI + MTX (Hazard Ratio [HR]
0.55, 95% Confidence Interval [CI]: 0.26 to 1.18).2 An estimated
rate of grade II-IV aGvHD-free survival of 50% was observed for the
Orencia IV + CNI + MTX group versus 32% for placebo + CNI + MTX (HR
0.54, 95% CI: 0.35 to 0.83).2 aGvHD-free survival was measured from
the date of transplantation until the onset of documented aGvHD or
death by any cause up to Day 180 post-transplantation. The rate of
estimated OS was 97% for the Orencia IV + CNI + MTX group versus
84% for placebo + CNI + MTX (HR 0.33, 95% CI: 0.12 to 0.93).2 In an
exploratory analysis of the 7/8 cohort of Orencia-treated patients
(n=43), the rates of grade III-IV aGvHD-free survival, grade II-IV
aGvHD-free survival, and OS at Day 180 post-transplantation were
95% (95% CI: 83% to 99%), 53% (95% CI: 38% to 67%), and 98% (95%
CI: 85% to 100%), respectively.2
Serious adverse events reported in >5% of patients who
received Orencia in combination with a CNI and MTX included pyrexia
(20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%),
hypoxia (5%), and nausea (5%).2 Permanent discontinuation of
Orencia occurred in two patients (1.7%) due to one case each of
pneumonia and allergic reaction.2
The most frequent adverse events of all grades reported in ≥10%
of patients with aGvHD who received Orencia with a difference of
≥2% for the 7/8 cohort, 8/8 cohort Orencia arm, and 8/8 cohort
placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4
lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%,
and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV
infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%),
epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and
10%), and hypermagnesemia (5%, 18%, 10%).2
Incidence rates of grade III or IV adverse events were the same
as incidence rates of all grades, with the exception of grade III
or IV pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort,
Orencia arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the
8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8
cohort Orencia arm (7%).2 Clinically relevant adverse reactions in
<10% of patients who received Orencia in combination with CNI
and MTX in Study GVHD-1 included EBV reactivation.2
Use of Orencia for this indication in patients 2 to less than 6
years of age is supported by pharmacokinetic modeling and
simulations of Orencia exposure.2 The safety and effectiveness of
Orencia have not been established in pediatric patients younger
than 2 years of age for prophylaxis of aGvHD.2
About GVHD-2
GVHD-2 – a second clinical study using data from the CIBMTR –
was conducted to analyze outcomes of Orencia in combination with
CNI and MTX for aGvHD prophylaxis in comparison to that of
recipients who received only CNI and MTX, in patients 6 years of
age or older undergoing HSCT from a 1 allele-mismatched URD between
2011 and 2018.2 The Orencia-treated group (n=54) included 42
patients from GVHD-1, in addition to 12 patients treated with
Orencia outside of GVHD-1.2 The comparator group (n=162) was
randomly selected in a 3:1 ratio to the Orencia-treated group from
the CIBMTR registry from patients who had not received Orencia
during the study period. Analyses used propensity score matching
and inverse probability of treatment weighting to help address the
impact of selection bias. Efficacy was based on OS at Day 180
post-HSCT.2 The OS rate at Day 180 in the Orencia in combination
with CNI and MTX group was 98% (95% CI: 78 to 100) and the OS rate
at Day 180 in the CNI and MTX group was 75% (95% CI: 67 to 82).2
Please see Important Safety Information below, and U.S. Full
Prescribing Information.
About Acute Graft Versus Host Disease and Impact on a Diverse
Patient Population
Hematopoietic stem cell transplant (HSCT) is an effective
treatment for hematological malignancies and other non-malignant
hematological diseases, often representing the only option for
cure.5 However, some of its benefit, especially in the case of
unrelated donor transplantation, is offset by a high rate of
transplant-related mortality stemming largely from severe acute
graft versus host disease (aGvHD) and infection.6 Acute graft
versus host disease after HSCT occurs when transplanted donor
T-cells recognize antigenic differences between the donor and the
recipient, and attack the recipient’s healthy tissue and organs.1
This activation of T-cells can result in severe immune-mediated
tissue damage to the host, with the skin, liver and
gastrointestinal tract being the most common targets.1 Acute graft
versus host disease mediated damage to these vital organs has been
associated with increased morbidity and death.1
Acute graft versus host disease impacts up to 70 percent of
patients who receive stem cell transplants, particularly those
coming from unrelated and human leukocyte antigen (HLA)-mismatched
donors.1 This can be of particular concern with racial and ethnic
minority patient populations following HSCT.1,3 This may be due to
several factors that impact overall outcome, including a lack of
donor availability or access to matched HSCTs and related
care.3
About ORENCIA
ORENCIA® is a selective costimulation modulator that disrupts
the continuous cycle of T-cell activation.
U.S. Indications/Usage and Important Safety Information for
ORENCIA® (abatacept)
Indications and Usage
Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is
indicated for the treatment of adult patients with moderately to
severely active rheumatoid arthritis (RA).
Polyarticular Juvenile Idiopathic Arthritis: ORENCIA is
indicated for the treatment of patients 2 years of age and older
with moderately to severely active polyarticular juvenile
idiopathic arthritis (pJIA).
Adult Psoriatic Arthritis: ORENCIA is indicated for the
treatment of adult patients with active psoriatic arthritis
(PsA).
Prophylaxis for Acute Graft versus Host Disease: ORENCIA
is indicated for the prophylaxis of acute graft versus host disease
(aGVHD), in combination with a calcineurin inhibitor and
methotrexate, in adults and pediatric patients 2 years of age or
older undergoing hematopoietic stem cell transplantation (HSCT)
from a matched or 1 allele-mismatched unrelated-donor.
Limitations of Use: The concomitant use of ORENCIA with
other potent immunosuppressants [e.g., biologic disease-modifying
antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is
not recommended.
Important Safety Information for ORENCIA® (abatacept)
Increased Risk of Infection with Concomitant Use with TNF
Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors:
Concurrent therapy with ORENCIA and a TNF antagonist is not
recommended. In controlled clinical trials, adult RA patients
receiving concomitant intravenous ORENCIA and TNF antagonist
therapy experienced more infections (63% vs 43%) and serious
infections (4.4% vs 0.8%) compared to patients treated with only
TNF antagonists, without an important enhancement of efficacy.
Additionally, concomitant use of ORENCIA with other biologic RA/PsA
therapy or JAK inhibitors is not recommended.
Hypersensitivity: There were 2 cases (<0.1%; n=2688)
of anaphylaxis reactions in clinical trials with adult RA patients
treated with intravenous ORENCIA. Other reactions potentially
associated with drug hypersensitivity, such as hypotension,
urticaria, and dyspnea, each occurred in <0.9% of patients.
There was one case of a hypersensitivity reaction with ORENCIA in
pJIA clinical trials (0.5%; n=190). In postmarketing experience,
fatal anaphylaxis following the first infusion of ORENCIA and
life-threatening cases of angioedema have been reported. Angioedema
has occurred as early as after the first dose of ORENCIA, but also
has occurred with subsequent doses. Angioedema reactions have
occurred within hours of administration and in some instances had a
delayed onset (i.e., days). Appropriate medical support measures
for treating hypersensitivity reactions should be available for
immediate use. If an anaphylactic or other serious allergic
reaction occurs, administration of intravenous or subcutaneous
ORENCIA should be stopped immediately and permanently discontinued,
with appropriate therapy instituted.
Infections: Serious infections, including sepsis and
pneumonia, were reported in 3% and 1.9% of RA patients treated with
intravenous ORENCIA and placebo, respectively. Some of these
infections have been fatal. Many of the serious infections have
occurred in patients on concomitant immunosuppressive therapy
which, in addition to their underlying disease, could further
predispose them to infection. Caution should be exercised in
patients with a history of infection or underlying conditions which
may predispose them to infections. Treatment with ORENCIA should be
discontinued if a patient develops a serious infection. Patients
should be screened for tuberculosis and viral hepatitis in
accordance with published guidelines, and if positive, treated
according to standard medical practice prior to therapy with
ORENCIA.
Immunizations: Prior to initiating ORENCIA in pediatric
and adult patients, update vaccinations in accordance with current
vaccination guidelines. Live vaccines should not be given
concurrently with ORENCIA or within 3 months after discontinuation.
ORENCIA may blunt the effectiveness of some immunizations. In
addition, it is unknown if the immune response of an infant who was
exposed in utero to abatacept and subsequently administered a live
vaccine is impacted. Risks and benefits should be considered prior
to vaccinating such infants.
Increased Risk of Adverse Reactions When Used in Patients
with Chronic Obstructive Pulmonary Disease (COPD): In Study V,
adult COPD patients treated with ORENCIA for RA developed adverse
events more frequently than those treated with placebo, including
COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97%
of COPD patients treated with ORENCIA developed adverse events
versus 88% treated with placebo. Respiratory disorders occurred
more frequently in patients treated with ORENCIA compared to those
on placebo (43% vs 24%, respectively), including COPD exacerbation,
cough, rhonchi, and dyspnea. A greater percentage of patients
treated with ORENCIA developed a serious adverse event compared to
those on placebo (27% vs 6%), including COPD exacerbation [3 of 37
patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of
ORENCIA in patients with COPD should be undertaken with caution,
and such patients monitored for worsening of their respiratory
status.
Immunosuppression: In clinical trials in adult RA
patients, a higher rate of infections was seen in ORENCIA-treated
patients compared to placebo-treated patients. The impact of
treatment with ORENCIA on the development and course of
malignancies is not fully understood. There have been reports of
malignancies, including skin cancer in patients receiving ORENCIA.
Periodic skin examinations are recommended for all ORENCIA-treated
patients, particularly those with risk factors for skin cancer.
Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV)
Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell
Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder
(PTLD) occurred in patients who received ORENCIA for aGVHD
prophylaxis during unrelated HSCT. Of 116 patients who received
ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events
were associated with Epstein-Barr virus (EBV) infection. The range
of time to onset of the event was 49 to 89 days post-transplant.
Monitor patients for EBV reactivation in accordance with
institutional practices. Before administering Orencia, provide
recommended prophylaxis for EBV infection and continue for 6 months
post-transplantation to prevent EBV-associated PTLD.
Cytomegalovirus (CMV) invasive disease occurred in patients who
received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of
116 patients who received ORENCIA, 7% (n=8) experienced CMV
invasive diseases up to day 225 post-transplant. The median time to
onset of the event was 91 days post-transplant. CMV invasive
diseases predominantly involved the gastrointestinal tract. Monitor
patients for CMV infection/reactivation for 6 months
post-transplant regardless of the results of donor and recipient
pre-transplant CMV serology. Consider prophylaxis for CMV
infection/reactivation during treatment and for six months
following HSCT.
Blood Glucose Testing: ORENCIA for intravenous
administration contains maltose, which may result in falsely
elevated blood glucose readings on the day of infusion when using
blood glucose monitors with test strips utilizing glucose
dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using
monitors and advising patients to use monitors that do not react
with maltose, such as those based on glucose dehydrogenase nicotine
adenine dinucleotide (GDH-NAD), glucose oxidase or glucose
hexokinase test methods. ORENCIA for subcutaneous (SC)
administration does not contain maltose; therefore, patients do not
need to alter their glucose monitoring.
Pregnancy: There are no adequate and well-controlled
studies of ORENCIA use in pregnant women and the data with ORENCIA
use in pregnant women are insufficient to inform on drug-associated
risk. A pregnancy registry has been established to monitor
pregnancy outcomes in women exposed to ORENCIA during pregnancy.
Healthcare professionals are encouraged to register patients by
calling 1-877-311-8972.
Lactation: There is no information regarding the presence
of abatacept in human milk, the effects on the breastfed infant, or
the effects on milk production. However, abatacept was present in
the milk of lactating rats dosed with abatacept.
Most Serious Adverse Reactions: In controlled clinical
trials, adult RA patients experienced serious infections (3%
ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1%
placebo). In the GVHD-1 study, serious adverse reactions reported
in >5% of patients who received ORENCIA in combination with a
calcineurin inhibitor and methotrexate and >2% higher than
placebo included pyrexia (20%), pneumonia (8%), acute kidney injury
(7%), diarrhea (6%), hypoxia (5%), and nausea (5%).
Malignancies: The overall frequency of malignancies was
similar between adult RA patients treated with ORENCIA or placebo.
However, more cases of lung cancer were observed in patients
treated with ORENCIA (0.2%) than those on placebo (0%). A higher
rate of lymphoma was seen compared to the general population;
however, patients with RA, particularly those with highly active
disease, are at a higher risk for the development of lymphoma. The
potential role of ORENCIA in the development of malignancies in
humans is unknown.
Most Frequent Adverse Events (≥10%): Headache, upper
respiratory tract infection, nasopharyngitis, and nausea were the
most commonly reported adverse events in the adult RA clinical
studies. Other events reported in ≥5% of pJIA patients were
diarrhea, cough, pyrexia, and abdominal pain. In general, the
adverse events in pediatric pJIA and adult PsA patients were
similar in frequency and type to those seen in adult RA patients.
The most frequent adverse reactions of all grades reported in ≥10%
of patients with aGVHD who received ORENCIA with a difference of
≥2% for the 7/8 cohort, 8/8 cohort Orencia arm, and 8/8 cohort
placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4
lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%,
and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV
infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%),
epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and
10%), and hypermagnesemia (5%, 18%, 10%).
Incidence rates of grade 3 or 4 adverse reactions were the same
as incidence rates of all grades, with the exception of grade 3 or
4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, Orencia
arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8
cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort
Orencia arm (7%). Clinically relevant adverse reactions in <10%
of patients who received ORENCIA in combination with calcineurin
inhibitor and methotrexate in Study GVHD-1 included EBV
reactivation.
Note concerning ORENCIA administration options: ORENCIA
may be administered as an intravenous infusion only for patients 6
years of age and older. PJIA patients may self-inject with ORENCIA
or the patient’s caregiver may administer ORENCIA if both the
healthcare practitioner and the parent/legal guardian determines it
is appropriate. The ability of pediatric patients to self-inject
with the autoinjector has not been tested. ORENCIA may only be
administered as an intravenous (IV) infusion for the prophylaxis of
aGVHD in patients undergoing HSCT. The safety and effectiveness of
ORENCIA have not been established in pediatric patients younger
than 2 years of age for prophylaxis of aGVHD.
Please click here for Full Prescribing Information.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
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Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of
Bristol-Myers Squibb Company. In certain countries outside the
U.S., due to local laws, Celgene and Juno Therapeutics are referred
to as, Celgene, a Bristol Myers Squibb company and Juno
Therapeutics, a Bristol Myers Squibb company.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, whether Orencia (abatacept), in combination with a
calcineurin inhibitor and methotrexate, for the indication
described in this release will be commercially successful, any
marketing approvals, if granted, may have significant limitations
on their use, and that continued approval of such combination
treatment for such indication described in this release may be
contingent upon verification and description of clinical benefit in
confirmatory trials. No forward-looking statement can be
guaranteed. Forward-looking statements in this press release should
be evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2020, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, Bristol Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
References
- Leukemia & Lymphoma Society. Graft-Versus Host Disease Fact
Sheet No. 32. Updated 12/06/2017.
https://www.lls.org/sites/default/files/National/USA/Pdf/Publications/FS32_GvHD_6.19_Update.pdf.
Accessed September 6, 2021.
- Orencia Prescribing Information. Orencia U.S. Product
Information. Last updated: December 2021. Princeton, NJ:
Bristol-Myers Squibb Company.
- Majhail, NS et al. Racial disparities in hematopoietic cell
transplantation in the United States. Bone Marrow Transplant. 2012
Nov;47(11): 10.1038/bmt.2011.214.
- Bristol-Myers Squibb Company. Abatacept. Primary Clinical Study
Report for Study IM101311: Abatacept Combined With a Calcineurin
Inhibitor and Methotrexate for Graft Versus Host Disease
Prophylaxis.
- Khandelwal P, Yeh RF, Yu L, et al. Graft-versus-host Disease
Prophylaxis With Abatacept Reduces Severe Acute Graft-versus-host
Disease in Allogeneic Hematopoietic Stem Cell Transplant for
Beta-thalassemia Major With Busulfan, Fludarabine, and Thiotepa.
Transplantation. 2021;105(4):891-896.
doi:10.1097/TP.0000000000003327
- Ochs L, Shu XO, Miller J, et al. Late infections after
allogeneic bone marrow transplantations: comparison of incidence in
related and unrelated donor transplant recipients. Blood.
1995;86(10):3979-86.
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