First presentation of data from the Phase 3
TRANSFORM study of CD19-directed CAR T cell therapy Breyanzi
(lisocabtagene maraleucel) in second-line relapsed or refractory
(R/R) large B-cell lymphoma
Research from industry-leading multiple
myeloma program with new analyses for the first-in-class anti-BCMA
CAR T cell therapy, Abecma (idecabtagene vicleucel), as well as
studies in heavily-treated disease highlighting CELMoD®s, with new
safety and efficacy results for iberdomide and first presentation
of combination data with CC-92480
First clinical results for anti-SIRPα
antibody CC-95251 and CELMoD® CC-99282 in patients
with R/R non-Hodgkin’s lymphoma showcasing pipeline potential
through multiple modalities
Bristol Myers Squibb (NYSE: BMY) today announced the
presentation of research across a wide range of hematologic
diseases at the 63rd American Society of Hematology (ASH) Annual
Meeting and Exposition, which will take place in Atlanta, Georgia,
and virtually, from December 11 to 14, 2021. Data from more than 80
company-sponsored studies will be featured, including 23 oral
presentations, highlighting key research and development programs
in lymphomas, leukemias, multiple myeloma and myeloid diseases, and
showcasing our commitment to delivering transformative medicines
across major hematologic diseases.
Key data being presented by Bristol Myers Squibb and its
partners at the 2021 ASH Annual Meeting and Exposition
include:
- First presentation of results from pivotal Phase 3 TRANSFORM
study evaluating CD19-directed chimeric antigen receptor (CAR) T
cell therapy Breyanzi (lisocabtagene maraleucel) head-to-head
against the current standard of care treatment approach for
second-line relapsed or refractory (R/R) large B-cell lymphoma
(LBCL)
- Two-year follow-up data from the pivotal TRANSCEND NHL 001
study of Breyanzi in third-line and later R/R LBCL
- First clinical results for anti-SIRPα antibody CC-95251 plus
rituximab, as well as first clinical results for CELMoD® CC-99282,
both in patients with R/R non-Hodgkin’s lymphoma
- First disclosure of safety and efficacy results from dose
expansion of the MM-001 study evaluating CELMoD® iberdomide in
combination with dexamethasone in patients with R/R multiple
myeloma
- First disclosure of preliminary results from the Phase 1/2
MM-002 study of CELMoD® CC-92480 in combination with dexamethasone
and bortezomib in patients with R/R multiple myeloma
- Further analyses from the pivotal KarMMa trial in R/R multiple
myeloma evaluated baseline predictors of complete responses and
outcomes for patients treated with subsequent anti-myeloma
therapies, including alternative B-cell maturation antigen
(BCMA)-directed therapies, after treatment with Abecma
(idecabtagene vicleucel),the first-in-class BCMA-directed CAR T
cell therapy
- Abstracts highlighting multiple Bristol Myers Squibb’s
therapies in hard-to-treat myeloid diseases, including longer-term
data and analyses of different acute myeloid leukemia subtypes and
baseline characteristics with Onureg® (azacitidine tablets) from
the Phase 3 QUAZAR® AML-001 study and safety with Inrebic®
(fedratinib) from the Phase 3b FREEDOM trial in myelofibrosis
- Updated analyses of Reblozyl® (luspatercept-aamt) from the
Phase 2 BEYOND study in beta thalassemia and from the Phase 3
MEDALIST study in lower-risk myelodysplastic syndromes
“Our presence at ASH continues our longstanding commitment to
hematology and underscores the potential of our innovative research
platforms to deliver meaningful, new treatment options for people
with unmet needs living with hematologic diseases,” said Samit
Hirawat, M.D., executive vice president, chief medical officer,
global drug development, Bristol Myers Squibb. “These data
reinforce our progress in advancing transformative research across
a wide range of hematologic malignancies including multiple
myeloma, lymphoma, and myeloid diseases.”
Selected Bristol Myers Squibb studies at the 63rd
ASH Annual Meeting and Exposition include:
Abstract Title
Author
Presentation Type/#
Session Title
Session Date/Time
Acute Myeloid Leukemia
Prognostic Impact of NPM1 and FLT3
Mutations at Diagnosis and Presence of Measurable Residual Disease
(MRD) after Intensive Chemotherapy (IC) for Patients with Acute
Myeloid Leukemia (AML) in Remission: Outcomes from the QUAZAR
AML-001 Trial of Oral Azacitidine (Oral-AZA) Maintenance
Hartmut D�hner
Oral
Abstract #804
617. Acute Myeloid Leukemia: Biomarkers,
Molecular Markers and Minimal Residual Disease in Diagnosis and
Prognosis: New options of risk assessment and prediction of therapy
response in AML
Monday, December 13,
5:45 PM
Long-term Overall Survival (OS) with Oral
Azacitidine (Oral-AZA) in Patients with Acute Myeloid Leukemia
(AML) in First Remission after Intensive Chemotherapy (IC): Updated
Results from the Phase 3 QUAZAR AML-001 Trial
Andrew Wei
Oral
Abstract #871
615. Acute Myeloid Leukemias: Commercially
Available Therapies, Excluding Transplantation and Cellular
Immunotherapies: Updates in treatment for high-risk
AML
Monday, December 13,
6:15 PM
Beta Thalassemia
Luspatercept Redistributes Body Iron to
the Liver in Transfusion-Dependent-Thalassemia (TDT) During
Erythropoietic Response
Maciej Garbowski
Oral Abstract
#761
102. Iron Homeostasis and Biology:
Disorders of Iron and Heme and Novel Treatments
Monday, December 13,
5:30 PM
Luspatercept Improves Health-Related
Quality of Life (HRQoL) Symptoms and RBC Transfusion Burden in
Patients with Non-Transfusion-Dependent β-thalassemia (NTDT) in the
BEYOND Trial
Antonis Kattamis
Poster Abstract #3081
112. Thalassemia and Globin Gene
Regulation: Poster III
Monday, December 13,
6:00 - 8:00 PM
Graft vs. Host Disease
Overall Survival of Patients Treated with
Abatacept in Combination with a Calcineurin Inhibitor and
Methotrexate After Allogeneic Hematopoietic Stem Cell
Transplantation - Analysis of the Center for International Blood
and Marrow Transplant Research Database
Leslie Kean
Poster Abstract #3912
722. Allogeneic Transplantation: Acute and
Chronic GVHD, Immune Reconstitution: Poster III
Monday, December 13, 6:00 – 8:00 PM
Lymphoma
Lisocabtagene Maraleucel (liso-cel), a
CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy,
Versus Standard of Care (SOC) with Salvage Chemotherapy (CT)
Followed by Autologous Stem Cell Transplantation (ASCT) as
Second-Line (2L) Treatment in Patients (Pts) with Relapsed or
Refractory (R/R) Large B-Cell Lymphoma (LBCL): Results from the
Randomized Phase 3 TRANSFORM Study
Manali Kamdar
Oral Abstract
#91
704. Cellular Immunotherapies: Cellular
Therapies for Lymphomas
Saturday, December 11,
9:30 AM
Ruxolitinib Plus Nivolumab in Patients
with R/R Hodgkin Lymphoma after Failure of Check-Point Inhibitors:
Preliminary Report on Safety and Efficacy
Veronika
Bachanova
Oral Abstract
#230
624. Hodgkin Lymphomas and T/NK cell
Lymphomas: Hodgkin Lymphoma Clinical Trials
Hematology Disease Topics &
Pathways:
Clinical Trials
Saturday, December 11, 2:15 PM
Nivolumab First-Line Therapy for Elderly
Hodgkin Lymphoma Patients: a LYSA Phase II Study
Julien Lazarovici
Oral Abstract
#232
624. Hodgkin Lymphomas and T/NK cell
Lymphomas: Hodgkin Lymphoma Clinical Trials
Saturday, December 11, 2:45 PM
OUTREACH: Results from a Phase 2 Study of
Lisocabtagene Maraleucel (liso-cel) Administered as Inpatient
(Inpt) or Outpatient (Outpt) Treatment in the Nonuniversity Setting
in Patients (Pts) with R/R Large B-Cell Lymphoma (LBCL)
John Godwin
Poster Abstract
#1762
704. Cellular Immunotherapies: Clinical:
Poster I
Saturday, December 11,
5:30 – 7:30 PM
Six-Year Results from the Phase 3
Randomized Study Relevance Show Similar Outcomes for Previously
Untreated Follicular Lymphoma Patients Receiving Lenalidomide Plus
Rituximab (R2) Versus Rituximab-Chemotherapy Followed By Rituximab
Maintenance
Franck Morschhauser
Poster Abstract
#2417
623. Mantle Cell, Follicular, and Other
Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster
II
Sunday, December 12,
6:00 - 8:00 PM
Differential Effects of Iberdomide Versus
Revlimid on Leukocyte Trafficking, Immune Activation and DLBCL
Tumor Cell Killing
Yumi Nakayama
Oral Abstract
#718
622. Lymphomas: Translational-Non-Genetic:
Lymphoma biology
Monday, December 13,
3:30 PM
Completed Induction Phase Analysis of
MAGNIFY: Phase 3b Study of Lenalidomide + Rituximab (R2) Followed
By Maintenance in Relapsed/Refractory Indolent Non-Hodgkin
Lymphoma
Frederick
Lansigan
Oral Abstract
#812
623. Mantle Cell, Follicular, and Other
B-Cell Lymphomas: Clinical and Epidemiological: Follicular
Lymphoma: Advances in Treatment Approaches
Monday, December 13,
4:45 PM
Discovery and Preclinical Characterization
of CC-95251, an Anti-SIRPa Antibody that Enhances
Macrophage-Mediated Phagocytosis of Non-Hodgkin Lymphoma (NHL)
Cells when Combined with Rituximab
Henry Chan
Poster Abstract
#2271
605. Molecular Pharmacology and Drug
Resistance: Lymphoid Neoplasms: Poster II
Monday, December 13,
6:00 - 8:00 PM
Characteristics of Post-Infusion Chimeric
Antigen Receptor (CAR) T Cells and Endogenous T Cells Associated
with Early and Long-term Response in Lisocabtagene Maraleucel
(liso-cel)–Treated Relapsed or Refractory (R/R) Large B-Cell
Lymphoma (LBCL)
Jerill Thorpe
Poster Abstract
#2417
704. Cellular Immunotherapies: Clinical:
Poster III
Monday, December 13,
6:00 - 8:00 PM
Two-Year Follow-up of TRANSCEND NHL 001, a
Multicenter Phase 1 Study of Lisocabtagene Maraleucel (liso-cel) in
Relapsed or Refractory (R/R) Large B-Cell Lymphomas (LBCL)
Jeremy Abramson
Poster Abstract
#2840
704. Cellular Immunotherapies: Clinical:
Poster III
Monday, December 13,
6:00 - 8:00 PM
Cost-effectiveness of Liso-cel versus
Axi-cel for Treatment of Relapsed or Refractory Large B-Cell
Lymphoma
Christopher Parker
Poster Abstract
#3003
902. Health Services Research—Lymphoid
Malignancies: Poster II
Monday, December 13,
6:00 - 8:00 PM
Clinical Activity of CC-99282, a Novel,
Oral Small Molecule Cereblon E3 Ligase Modulator (CELMoD) Agent, in
Patients (Pts) with Relapsed or Refractory Non-Hodgkin Lymphoma
(R/R NHL) – First Results from a Phase 1, Open-Label Study
Jean-Marie Michot
Poster Abstract
#3574
626. Aggressive Lymphomas: Prospective
Therapeutic Trials: Poster III
Monday, December 13,
6:00 - 8:00 PM
Multiple Myeloma
Iberdomide (IBER) in Combination with
Dexamethasone (DEX) in Patients (pts) with Relapsed/Refractory
Multiple Myeloma (RRMM): Results from the Dose-Expansion Phase of
the CC-220-MM-001 Trial
Sagar Lonial
Oral Abstract #162
653. Myeloma and Plasma Cell Dyscrasias:
Clinical-Prospective Therapeutic Trials: Novel Targets and
Amyloid
Saturday, December 11, 1:15 PM
Real-World Treatment Patterns and
Clinical, Economic, and Humanistic Burden in Triple-Class
Refractory Multiple Myeloma: Analysis of the CONNECT® Multiple
Myeloma (MM) Disease Registry
Sundar Jagannath
Oral Abstract
#117
905. Outcomes Research- Lymphoid
Malignancies: Multiple Myeloma and Other Plasma Cell Disorders
Saturday, December 11,
10:00 AM
Baseline Correlates of Complete Response
to Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T
Cell Therapy in Patients with Relapsed and Refractory Multiple
Myeloma: Subanalysis of the KarMMa Trial
Nina Shah
Poster Abstract
#1739
704. Cellular Immunotherapies: Clinical:
Poster I
Saturday, December 11 5:30 - 7:30 PM
Matching-Adjusted Indirect Comparisons of
Efficacy Outcomes in Patients with Relapsed and Refractory Multiple
Myeloma for Idecabtagene Vicleucel (KarMMa) vs. Selinexor Plus
Dexamethasone (STORM Part 2) and Belantamab Mafodontin (DREAMM-2):
Updated Analysis with Longer Follow-up
Paula Rodriguez-Otero
Poster Abstract
#1978
905. Outcomes Research—Lymphoid
Malignancies: Poster I
Saturday, December 11,
5:30 – 7:30 PM
Updated Clinical and Correlative Results
From the Phase I CRB-402 Study of the BCMA-Targeted CAR-T Cell
Therapy bb21217 in Patients with Relapsed and Refractory Multiple
Myeloma
Noopur Raje
Oral Abstract #548
Cellular Immunotherapies: Cellular
Therapies for Myeloma
Sunday, December 12
4:45 PM
CC-92480, a Potent, Novel Cereblon E3
Ligase Modulator (CELMoD) Agent, in Combination with Dexamethasone
(DEX) and Bortezomib (BORT) in Patients (pts) with
Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results
from the Phase 1/2 Study CC-92480-MM-002
Paul Richardson
Poster Abstract
#2731
653. Myeloma and Plasma Cell Dyscrasias:
Clinical-Prospective Therapeutic Trials: Poster II
Sunday, December 12
6:00 - 8:00 PM
Subsequent Anti-myeloma Therapy after
Idecabtagene Vicleucel (Ide-cel, bb2121) Treatment in Patients with
Relapsed/Refractory Multiple Myeloma from the KarMMa Study
Paula Rodriguez-Otero
Poster Abstract
#2743
653. Myeloma and Plasma Cell Dyscrasias:
Clinical-Prospective Therapeutic Trials: Poster II
Sunday, December 12 6:00 – 8:00 PM
Updated Health-Related Quality of Life
Results from the KarMMa Clinical Study in Patients with Relapsed
and Refractory Multiple Myeloma Treated with the B-Cell Maturation
Antigen-Directed Chimeric Antigen Receptor T Cell Therapy
Idecabtagene Vicleucel (ide-cel, bb2121)
Michel Delforge
Poster Abstract
#2835
704. Cellular Immunotherapies: Clinical:
Poster II
Sunday, December 12, 6:00 – 8:00 PM
Idecabtagene Vicleucel (ide-cel, bb2121),
a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T
Cell Therapy: Qualitative Analyses of Post-Treatment Interviews
(Months 6–24) for Patients with Relapsed and Refractory Multiple
Myeloma in the KarMMa Clinical Trial
Nina Shah
Poster Abstract
#3041
Session Name: 905. Outcomes
Research—Lymphoid Malignancies: Poster II
Sunday, December 12 6:00 – 8:00 PM
Large-Scale Mass Cytometry Reveals
Significant Activation of Innate and Adaptive Immunity in Bone
Marrow Tumor Microenvironment of Iberdomide-Treated Myeloma
Patients
Oliver Van Oekelen
Oral Abstract
#730
651. Multiple Myeloma and Plasma Cell
Dyscrasias: Basic and Translational: The Myeloma Immune
Microenvironment
Monday, December 13, 3:30 PM
Myelodysplastic Syndrome
Treatment Duration and Exposure Adjusted
Safety Analysis in the MEDALIST Study (luspatercept)
Uwe Platzbecker
Poster Abstract
#1524
637. Myelodysplastic Syndromes — Clinical
and Epidemiological: Poster I
Saturday, December 11 5:30 - 7:30
PM
Myelofibrosis
Safety and Tolerability of Fedratinib, an
Oral Inhibitor of Janus Kinase 2 (JAK2), in Patients with
Intermediate- or High-risk Myelofibrosis (MF) Previously Treated
with Ruxolitinib: Results from the Phase 3b FREEDOM Trial
Vikas Gupta
Oral Abstract
#389
634. Myeloproliferative Syndromes:
Clinical and Epidemiological: Novel Therapies for MPNs and JAK
inhibitors for Myelofibrosis
Sunday, December 12, 10:30 AM
Spleen and Symptom Responses with
Fedratinib (FEDR) Patients with Myelofibrosis (MF) and Substantial
Splenomegaly
Jean‐Jacques Kiladjian
Poster Abstract
#2576
634. Myeloproliferative Syndromes:
Clinical and Epidemiological: Poster II
Sunday, December 12 6:00 - 8:00 PM
Bristol Myers Squibb: Creating a Better
Future for Cancer Patients
Bristol Myers Squibb is inspired by a single vision —
transforming patients’ lives through science. The goal of the
company’s cancer research is to deliver medicines that offer each
patient a better, healthier life and to make cure a possibility.
Building on a legacy across a broad range of cancers that have
changed survival expectations for many, Bristol Myers Squibb
researchers are exploring new frontiers in personalized medicine,
and through innovative digital platforms, are turning data into
insights that sharpen their focus. Deep scientific expertise,
cutting-edge capabilities and discovery platforms enable the
company to look at cancer from every angle. Cancer can have a
relentless grasp on many parts of a patient’s life, and Bristol
Myers Squibb is committed to taking actions to address all aspects
of care, from diagnosis to survivorship. Because as a leader in
cancer care, Bristol Myers Squibb is working to empower all people
with cancer to have a better future.
BREYANZI
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T
cell therapy with a defined composition and 4-1BB costimulatory
domain. Breyanzi is administered as a defined composition to reduce
variability of the CD8 and CD4 component dose. The 4-1BB signaling
domain enhances the expansion and persistence of the CAR T
cells.
Indications
Breyanzi is approved by the U.S. Food and Drug Administration
for the treatment of adult patients with relapsed or refractory
(R/R) large B-cell lymphoma after two or more lines of systemic
therapy, including diffuse large B cell lymphoma (DLBCL) not
otherwise specified (including DLBCL arising from indolent
lymphoma), high-grade B-cell lymphoma, primary mediastinal large
B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is also
approved in Japan for the treatment of patients with R/R LBCL and
follicular lymphoma.
U.S. Important Safety
Information
BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC
TOXICITIES
- Cytokine Release Syndrome (CRS), including fatal or
life-threatening reactions, occurred in patients receiving
BREYANZI. Do not administer BREYANZI to patients with active
infection or inflammatory disorders. Treat severe or
life-threatening CRS with tocilizumab with or without
corticosteroids.
- Neurologic toxicities, including fatal or life-threatening
reactions, occurred in patients receiving BREYANZI, including
concurrently with CRS, after CRS resolution or in the absence of
CRS. Monitor for neurologic events after treatment with BREYANZI.
Provide supportive care and/or corticosteroids as needed.
- BREYANZI is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI
REMS.
Cytokine Release Syndrome (CRS)
CRS, including fatal or life-threatening reactions, occurred
following treatment with BREYANZI. CRS occurred in 46% (122/268) of
patients receiving BREYANZI, including ≥ Grade 3 (Lee grading
system) CRS in 4% (11/268) of patients. One patient had fatal CRS
and 2 had ongoing CRS at time of death. The median time to onset
was 5 days (range: 1 to 15 days). CRS resolved in 119 of 122
patients (98%) with a median duration of 5 days (range: 1 to 17
days). Median duration of CRS was 5 days (range 1 to 30 days) in
all patients, including those who died or had CRS ongoing at time
of death.
Among patients with CRS, the most common manifestations of CRS
include fever (93%), hypotension (49%), tachycardia (39%), chills
(28%), and hypoxia (21%). Serious events that may be associated
with CRS include cardiac arrhythmias (including atrial fibrillation
and ventricular tachycardia), cardiac arrest, cardiac failure,
diffuse alveolar damage, renal insufficiency, capillary leak
syndrome, hypotension, hypoxia, and hemophagocytic
lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
Ensure that 2 doses of tocilizumab are available prior to
infusion of BREYANZI. Sixty-one of 268 (23%) patients received
tocilizumab and/or a corticosteroid for CRS after infusion of
BREYANZI. Twenty-seven (10%) patients received tocilizumab only, 25
(9%) received tocilizumab and a corticosteroid, and 9 (3%) received
corticosteroids only.
Neurologic Toxicities
Neurologic toxicities that were fatal or life-threatening,
occurred following treatment with BREYANZI. CAR T cell-associated
neurologic toxicities occurred in 35% (95/268) of patients
receiving BREYANZI, including ≥ Grade 3 in 12% (31/268) of
patients. Three patients had fatal neurologic toxicity and 7 had
ongoing neurologic toxicity at time of death. The median time to
onset of the first event was 8 days (range: 1 to 46 days). The
onset of all neurologic events occurred within the first 8 weeks
following BREYANZI infusion. Neurologic toxicities resolved in 81
of 95 patients (85%) with a median duration of 12 days (range: 1 to
87 days). Three of four patients with ongoing neurologic toxicity
at data cutoff had tremor and one subject had encephalopathy.
Median duration of neurologic toxicity was 15 days (range: 1 to 785
days) in all patients, including those with ongoing neurologic
events at the time of death or at data cutoff.
Seventy-eight (78) of 95 (82%) patients with neurologic toxicity
experienced CRS. Neurologic toxicity overlapped with CRS in 57
patients. The onset of neurologic toxicity was after onset of CRS
in 30 patients, before CRS onset in 13 patients, same day as CRS
onset in 7 patients, and same day as CRS resolution in 7
patients.
Neurologic toxicity resolved in three patients before the onset
of CRS. Eighteen patients experienced neurologic toxicity after
resolution of CRS.
The most common neurologic toxicities included encephalopathy
(24%), tremor (14%), aphasia (9%), delirium (7%), headache (7%),
dizziness (6%), and ataxia (6%). Serious events including cerebral
edema and seizures occurred with BREYANZI. Fatal and serious cases
of leukoencephalopathy, some attributable to fludarabine, have
occurred in patients treated with BREYANZI.
CRS and Neurologic Toxicities Monitoring
Monitor patients daily at a certified healthcare facility during
the first week following infusion, for signs and symptoms of CRS
and neurologic toxicities. Monitor patients for signs and symptoms
of CRS and neurologic toxicities for at least 4 weeks after
infusion; evaluate and treat promptly. Counsel patients to seek
immediate medical attention should signs or symptoms of CRS or
neurologic toxicity occur at any time. At the first sign of CRS,
institute treatment with supportive care, tocilizumab or
tocilizumab and corticosteroids as indicated.
BREYANZI REMS
Because of the risk of CRS and neurologic toxicities, BREYANZI
is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
The required components of the BREYANZI REMS are:
- Healthcare facilities that dispense and administer BREYANZI
must be enrolled and comply with the REMS requirements.
- Certified healthcare facilities must have on-site, immediate
access to tocilizumab.
- Ensure that a minimum of 2 doses of tocilizumab are available
for each patient for infusion within 2 hours after BREYANZI
infusion, if needed for treatment of CRS.
- Certified healthcare facilities must ensure that healthcare
providers who prescribe, dispense, or administer BREYANZI are
trained on the management of CRS and neurologic toxicities.
Further information is available at www.BreyanziREMS.com, or
contact Bristol Myers Squibb at 1-888-423-5436.
Hypersensitivity Reactions
Allergic reactions may occur with the infusion of BREYANZI.
Serious hypersensitivity reactions, including anaphylaxis, may be
due to dimethyl sulfoxide (DMSO).
Serious Infections
Severe infections, including life-threatening or fatal
infections, have occurred in patients after BREYANZI infusion.
Infections (all grades) occurred in 45% (121/268) of patients.
Grade 3 or higher infections occurred in 19% of patients. Grade 3
or higher infections with an unspecified pathogen occurred in 16%
of patients, bacterial infections occurred in 5%, and viral and
fungal infections occurred in 1.5% and 0.4% of patients,
respectively. Monitor patients for signs and symptoms of infection
before and after BREYANZI administration and treat appropriately.
Administer prophylactic antimicrobials according to standard
institutional guidelines. Febrile neutropenia has been observed in
9% (24/268) of patients after BREYANZI infusion 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.
Avoid administration of BREYANZI in patients with clinically
significant active systemic infections.
Viral reactivation: 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. Ten of the 11 patients in the TRANSCEND study with a prior
history of HBV were treated with concurrent antiviral suppressive
therapy to prevent HBV reactivation during and after treatment with
BREYANZI. Perform screening for HBV, HCV, and HIV in accordance
with clinical guidelines before collection of cells for
manufacturing.
Prolonged Cytopenias
Patients may exhibit cytopenias not resolved for several weeks
following lymphodepleting chemotherapy and BREYANZI infusion. Grade
3 or higher cytopenias persisted at Day 29 following BREYANZI
infusion in 31% (84/268) of patients, and included thrombocytopenia
(26%), neutropenia (14%), and anemia (3%). Monitor complete blood
counts prior to and after BREYANZI administration.
Hypogammaglobulinemia
B-cell aplasia and hypogammaglobulinemia can occur in patients
receiving treatment with BREYANZI. The adverse event of
hypogammaglobulinemia was reported as an adverse reaction in 14%
(37/268) of patients; laboratory IgG levels fell below 500 mg/dL
after infusion in 21% (56/268) of patients. Hypogammaglobulinemia,
either as an adverse reaction or laboratory IgG level below 500
mg/dL after infusion, was reported in 32% (85/268) of patients.
Monitor immunoglobulin levels after treatment with BREYANZI and
manage using infection precautions, antibiotic prophylaxis, and
immunoglobulin replacement as clinically indicated. Live vaccines:
The safety of immunization with live viral vaccines during or
following BREYANZI 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 BREYANZI
treatment, and until immune recovery following treatment with
BREYANZI.
Secondary Malignancies
Patients treated with BREYANZI may develop secondary
malignancies. Monitor lifelong for secondary malignancies. In the
event that a secondary malignancy occurs, contact Bristol Myers
Squibb at 1-888-805-4555 for reporting and to obtain instructions
on collection of patient samples for testing.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered
mental status or seizures, patients receiving BREYANZI are at risk
for altered or decreased consciousness or impaired coordination in
the 8 weeks following BREYANZI administration. 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
Serious adverse reactions occurred in 46% of patients. The most
common nonlaboratory, serious adverse reactions (> 2%) were CRS,
encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia,
fever, hypotension, dizziness, and delirium. Fatal adverse
reactions occurred in 4% of patients.
The most common nonlaboratory adverse reactions of any grade (≥
20%) were fatigue, CRS, musculoskeletal pain, nausea, headache,
encephalopathy, infections (pathogen unspecified), decreased
appetite, diarrhea, hypotension, tachycardia, dizziness, cough,
constipation, abdominal pain, vomiting, and edema.
Please see full Prescribing Information, including Boxed
WARNINGS and Medication Guide.
ABECMA Indications
ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen
(BCMA)-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult patients with
relapsed or refractory multiple myeloma after four or more prior
lines of therapy, including an immunomodulatory agent, a proteasome
inhibitor, and an anti-CD38 monoclonal antibody.
Important Safety
Information
BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC
TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA
- Cytokine Release Syndrome (CRS), including fatal or
life-threatening reactions, occurred in patients following
treatment with ABECMA. Do not administer ABECMA to patients with
active infection or inflammatory disorders. Treat severe or
life-threatening CRS with tocilizumab or tocilizumab and
corticosteroids.
- Neurologic Toxicities, which may be severe or life-threatening,
occurred following treatment with ABECMA, including concurrently
with CRS, after CRS resolution, or in the absence of CRS. Monitor
for neurologic events after treatment with ABECMA. Provide
supportive care and/or corticosteroids as needed.
- Hemophagocytic Lymphohistiocytosis/Macrophage Activation
Syndrome (HLH/MAS) including fatal and life-threatening reactions,
occurred in patients following treatment with ABECMA. HLH/MAS can
occur with CRS or neurologic toxicities.
- Prolonged Cytopenia with bleeding and infection, including
fatal outcomes following stem cell transplantation for
hematopoietic recovery, occurred following treatment with
ABECMA.
- ABECMA is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA
REMS.
Cytokine Release Syndrome (CRS): CRS, including fatal or
life-threatening reactions, occurred following treatment with
ABECMA. CRS occurred in 85% (108/127) of patients receiving ABECMA.
Grade 3 or higher CRS (Lee grading system) occurred in 9% (12/127)
of patients, with Grade 5 CRS reported in one (0.8%) patient. The
median time to onset of CRS, any grade, was 1 day (range: 1 - 23
days) and the median duration of CRS was 7 days (range: 1 - 63
days) in all patients including the patient who died. The most
common manifestations of CRS included pyrexia (98%), hypotension
(41%), tachycardia (35%), chills (31%), hypoxia (20%), fatigue
(12%), and headache (10%). Grade 3 or higher events that may be
associated with CRS include hypotension, hypoxia,
hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress
syndrome (ARDS), atrial fibrillation, hepatocellular injury,
metabolic acidosis, pulmonary edema, multiple organ dysfunction
syndrome and HLH/MAS.
Identify CRS based on clinical presentation. Evaluate for and
treat other causes of fever, hypoxia, and hypotension. CRS has been
reported to be associated with findings of HLH/MAS, and the
physiology of the syndromes may overlap. HLH/MAS is a potentially
life-threatening condition. In patients with progressive symptoms
of CRS or refractory CRS despite treatment, evaluate for evidence
of HLH/MAS.
Fifty four percent (68/127) of patients received tocilizumab;
35% (45/127) received a single dose while 18% (23/127) received
more than 1 dose of tocilizumab. Overall, across the dose levels,
15% (19/127) of patients received at least 1 dose of
corticosteroids for treatment of CRS. All patients that received
corticosteroids for CRS received tocilizumab.
Overall rate of CRS was 79% and rate of Grade 2 CRS was 23% in
patients treated in the 300 x 106 CAR+ T cell dose cohort. For
patients treated in the 450 x 106 CAR+ T cell dose cohort, the
overall rate of CRS was 96% and rate of Grade 2 CRS was 40%. Rate
of Grade 3 or higher CRS was similar across the dose range. The
median duration of CRS for the 450 x 106 CAR+ T cell dose cohort
was 7 days (range: 1-63 days) and for the 300 x 106 CAR+ T cell
dose cohort was 6 days (range: 2-28 days). In the 450 x 106 CAR+ T
cell dose cohort, 68% (36/53) of patients received tocilizumab and
23% (12/53) received at least 1 dose of corticosteroids for
treatment of CRS. In the 300 x 106 CAR+ T cell dose cohort, 44%
(31/70) of patients received tocilizumab and 10% (7/70) received
corticosteroids. All patients that received corticosteroids for CRS
also received tocilizumab. Ensure that a minimum of 2 doses of
tocilizumab are available prior to infusion of ABECMA.
Monitor patients at least daily for 7 days following ABECMA
infusion at the REMS-certified healthcare facility for signs and
symptoms of CRS. Monitor patients for signs or symptoms of CRS for
at least 4 weeks after infusion. At the first sign of CRS,
institute treatment with supportive care, tocilizumab and/or
corticosteroids as indicated.
Counsel patients to seek immediate medical attention should
signs or symptoms of CRS occur at any time.
Neurologic Toxicities: Neurologic toxicities, which may
be severe or life-threatening, occurred following treatment with
ABECMA, including concurrently with CRS, after CRS resolution, or
in the absence of CRS. CAR T cell-associated neurotoxicity occurred
in 28% (36/127) of patients receiving ABECMA, including Grade 3 in
4% (5/127) of patients. One patient had ongoing Grade 2
neurotoxicity at the time of death. Two patients had ongoing Grade
1 tremor at the time of data cutoff. The median time to onset of
neurotoxicity was 2 days (range: 1 - 42 days). CAR T
cell-associated neurotoxicity resolved in 92% (33/36) of patients
with a median duration of neurotoxicity was 5 days (range: 1 - 61
days). The median duration of neurotoxicity was 6 days (range: 1 -
578) in all patients including those with ongoing neurotoxicity at
the time of death or data cut off. Thirty-four patients with
neurotoxicity had CRS. Neurotoxicity had onset in 3 patients
before, 29 patients during, and 2 patients after CRS. The rate of
Grade 3 neurotoxicity was 8% in the 450 x 106 CAR+ T cell dose
cohort and 1.4% in the 300 x 106 CAR+ T cell dose cohort. The most
frequently reported (greater than or equal to 5%) manifestations of
CAR T cell-associated neurotoxicity include encephalopathy (20%),
tremor (9%), aphasia (7%), and delirium (6%). Grade 4 neurotoxicity
and cerebral edema in 1 patient has been reported with ABECMA in
another study in multiple myeloma. Grade 3 myelitis and Grade 3
parkinsonism have been reported after treatment with ABECMA in
another study in multiple myeloma.
Monitor patients at least daily for 7 days following ABECMA
infusion at the REMS-certified healthcare facility for signs and
symptoms of neurologic toxicities. Rule out other causes of
neurologic symptoms. Monitor patients for signs or symptoms of
neurologic toxicities for at least 4 weeks after infusion and treat
promptly. Neurologic toxicity should be managed with supportive
care and/or corticosteroids as needed.
Counsel patients to seek immediate medical attention should
signs or symptoms of neurologic toxicity occur at any time.
Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage
Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of
patients receiving ABECMA. One patient treated in the 300 x 106
CAR+ T cell dose cohort developed fatal multi-organ HLH/MAS with
CRS. In another patient with fatal bronchopulmonary aspergillosis,
HLH/MAS was contributory to the fatal outcome. Three cases of Grade
2 HLH/MAS resolved. The rate of HLH/MAS was 8% in the 450 x 106
CAR+ T cell dose cohort and 1% in the 300 x 106 CAR+ T cell dose
cohort. All events of HLH/MAS had onset within 10 days of receiving
ABECMA with a median onset of 7 days (range: 4-9 days) and occurred
in the setting of ongoing or worsening CRS. Two patients with
HLH/MAS had overlapping neurotoxicity. The manifestations of
HLH/MAS include hypotension, hypoxia, multiple organ dysfunction,
renal dysfunction, and cytopenia. HLH/MAS is a potentially
life-threatening condition with a high mortality rate if not
recognized early and treated. Treatment of HLH/MAS should be
administered per institutional standards.
ABECMA REMS: Due to the risk of CRS and neurologic
toxicities, ABECMA is available only through a restricted program
under a Risk Evaluation and Mitigation Strategy (REMS) called the
ABECMA REMS. Further information is availableat www.AbecmaREMS.com
or 18884235436.
Hypersensitivity Reactions: Allergic reactions may occur
with the infusion of ABECMA. Serious hypersensitivity reactions,
including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in
ABECMA.
Infections: ABECMA should not be administered to patients
with active infections or inflammatory disorders. Severe,
life-threatening, or fatal infections occurred in patients after
ABECMA infusion. Infections (all grades) occurred in 70% of
patients. Grade 3 or 4 infections occurred in 23% of patients.
Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%)
had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5
bronchopulmonary aspergillosis, and 1 patient (0.8%) had
cytomegalovirus (CMV) pneumonia associated with Pneumocystis
jirovecii. Monitor patients for signs and symptoms of infection
before and after ABECMA infusion and treat appropriately.
Administer prophylactic, preemptive, and/or therapeutic
antimicrobials according to standard institutional guidelines.
Febrile neutropenia was observed in 16% (20/127) of patients
after ABECMA infusion 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.
Viral Reactivation: Cytomegalovirus (CMV) infection resulting in
pneumonia and death has occurred following ABECMA administration.
Monitor and treat for CMV reactivation in accordance with clinical
guidelines. 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 plasma cells.
Perform screening for CMV, HBV, hepatitis C virus (HCV), and human
immunodeficiency virus (HIV) in accordance with clinical guidelines
before collection of cells for manufacturing.
Prolonged Cytopenias: Patients may exhibit prolonged
cytopenias following lymphodepleting chemotherapy and ABECMA
infusion. In the KarMMa study, 41% of patients (52/127) experienced
prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced
prolonged Grade 3 or 4 thrombocytopenia that had not resolved by
Month 1 following ABECMA infusion. Rate of prolonged neutropenia
was 49% in the 450 x 106 CAR+ T cell dose cohort and 34% in the 300
x 106 CAR+ T cell dose cohort. In 83% (43/52) of patients who
recovered from Grade 3 or 4 neutropenia after Month 1, the median
time to recovery from ABECMA infusion was 1.9 months. In 65%
(40/62) of patients who recovered from Grade 3 or 4
thrombocytopenia, the median time to recovery was 2.1 months.
Median time to cytopenia recovery was similar across the 300 and
450 x 106 dose cohort.
Three patients underwent stem cell therapy for hematopoietic
reconstitution due to prolonged cytopenia. Two of the three
patients died from complications of prolonged cytopenia. Monitor
blood counts prior to and after ABECMA infusion. Manage cytopenia
with myeloid growth factor and blood product transfusion support
according to institutional guidelines.
Hypogammaglobulinemia: Plasma cell aplasia and
hypogammaglobulinemia can occur in patients receiving treatment
with ABECMA. Hypogammaglobulinemia was reported as an adverse event
in 21% (27/127) of patients; laboratory IgG levels fell below 500
mg/dl after infusion in 25% (32/127) of patients treated with
ABECMA.
Monitor immunoglobulin levels after treatment with ABECMA and
administer IVIG for IgG <400 mg/dl. Manage per local
institutional guidelines, including infection precautions and
antibiotic or antiviral prophylaxis.
The safety of immunization with live viral vaccines during or
following ABECMA 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 ABECMA
treatment, and until immune recovery following treatment with
ABECMA.
Secondary Malignancies: Patients treated with ABECMA may
develop secondary malignancies. Monitor life-long for secondary
malignancies. If a secondary malignancy occurs, contact Bristol
Myers Squibb at 1-888-805-4555 to obtain instructions on patient
samples to collect for testing of secondary malignancy of T cell
origin.
Effects on Ability to Drive and Operate Machinery: Due to
the potential for neurologic events, including altered mental
status or seizures, patients receiving ABECMA are at risk for
altered or decreased consciousness or coordination in the 8 weeks
following ABECMA 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 nonlaboratory adverse
reactions (incidence greater than or equal to 20%) include CRS,
infections – pathogen unspecified, fatigue, musculoskeletal pain,
hypogammaglobulinemia, diarrhea, upper respiratory tract infection,
nausea, viral infections, encephalopathy, edema, pyrexia, cough,
headache, and decreased appetite.
Please see full Prescribing Information, including Boxed
WARNINGS and Medication Guide.
ONUREG U.S. Indication
ONUREG® (azacitidine tablets) is approved in the U.S. for
continued treatment of adult patients with acute myeloid leukemia
who achieved first complete remission (CR) or complete remission
with incomplete blood count recovery (CRi) following intensive
induction chemotherapy and are not able to complete intensive
curative therapy.
U.S. Important Safety
Information
CONTRAINDICATIONS
- ONUREG is contraindicated in patients with known severe
hypersensitivity to azacitidine or its components.
WARNINGS AND PRECAUTIONS
- Risks of Substitution with Other
Azacitidine Products: Due to substantial differences in
the pharmacokinetic parameters, the recommended dose and schedule
for ONUREG are different from those for the intravenous or
subcutaneous azacitidine products. Treatment of patients using
intravenous or subcutaneous azacitidine at the recommended dosage
of ONUREG may result in a fatal adverse reaction. Treatment with
ONUREG at the doses recommended for intravenous or subcutaneous
azacitidine may not be effective. Do not substitute ONUREG for
intravenous or subcutaneous azacitidine.
- Myelosuppression: New or
worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in
49% and 22% of patients who received ONUREG. Febrile neutropenia
occurred in 12%. A dose reduction was required for 7% and 2% of
patients due to neutropenia and thrombocytopenia. Less than 1% of
patients discontinued ONUREG due to either neutropenia or
thrombocytopenia. Monitor complete blood counts and modify the
dosage as recommended. Provide standard supportive care, including
hematopoietic growth factors, if myelosuppression occurs.
- Increased Early Mortality in Patients
with Myelodysplastic Syndromes (MDS): In AZA-MDS-003,
216 patients with red blood cell transfusion-dependent anemia and
thrombocytopenia due to MDS were randomized to ONUREG or placebo.
107 received a median of 5 cycles of ONUREG 300 mg daily for 21
days of a 28-day cycle. Enrollment was discontinued early due to a
higher incidence of early fatal and/or serious adverse reactions in
the ONUREG arm compared with placebo. The most frequent fatal
adverse reaction was sepsis. Safety and effectiveness of ONUREG for
MDS have not been established. Treatment of MDS with ONUREG is not
recommended outside of controlled trials.
- Embryo-Fetal Toxicity:
ONUREG can cause fetal harm when administered to a pregnant woman.
Azacitidine caused fetal death and anomalies in pregnant rats via a
single intraperitoneal dose less than the recommended human daily
dose of oral azacitidine on a mg/m2 basis. Advise pregnant women of
the potential risk to a fetus. Advise females of reproductive
potential to use effective contraception during treatment with
ONUREG and for at least 6 months after the last dose. Advise males
with female partners of reproductive potential to use effective
contraception during treatment with ONUREG and for at least 3
months after the last dose.
ADVERSE REACTIONS
- Serious adverse reactions occurred in 15% of patients who
received ONUREG. Serious adverse reactions in ≥2% included
pneumonia (8%) and febrile neutropenia (7%). One fatal adverse
reaction (sepsis) occurred in a patient who received ONUREG.
- Most common (≥10%) adverse reactions with ONUREG vs placebo
were nausea (65%, 24%), vomiting (60%, 10%), diarrhea (50%, 21%),
fatigue/asthenia (44%, 25%), constipation (39%, 24%), pneumonia
(27%, 17%), abdominal pain (22%, 13%), arthralgia (14%, 10%),
decreased appetite (13%, 6%), febrile neutropenia (12%, 8%),
dizziness (11%, 9%), pain in extremity (11%, 5%).
LACTATION
- There are no data regarding the presence of azacitidine in
human milk or the effects on the breastfed child or milk
production. Because of the potential for serious adverse reactions
in the breastfed child, advise women not to breastfeed during
treatment with ONUREG and for 1 week after the last dose
REBLOZYL Indication
REBLOZYL is indicated for the treatment of anemia in adult
patients with beta thalassemia who require regular red blood cell
(RBC) transfusions
REBLOZYL is indicated for the treatment of anemia failing an
erythropoiesis stimulating agent and requiring 2 or more red blood
cell units over 8 weeks in adult patients with very low- to
intermediate-risk myelodysplastic syndromes with ring sideroblasts
(MDS-RS) or with myelodysplastic/ myeloproliferative neoplasm with
ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)
REBLOZYL is not indicated for use as a substitute for RBC
transfusions in patients who require immediate correction of
anemia
Important Safety
Information
WARNINGS AND PRECAUTIONS
Thrombosis/Thromboembolism
In adult patients with beta thalassemia, thromboembolic events
(TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs
included deep vein thrombosis, pulmonary embolus, portal vein
thrombosis, and ischemic stroke. Patients with known risk factors
for thromboembolism (splenectomy or concomitant use of hormone
replacement therapy) may be at further increased risk of
thromboembolic conditions. Consider thromboprophylaxis in patients
at increased risk of TEE. Monitor patients for signs and symptoms
of thromboembolic events and institute treatment promptly.
Hypertension
Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated
patients. Across clinical studies, the incidence of Grade 3 to 4
hypertension ranged from 1.8% to 8.6%. In patients with beta
thalassemia with normal baseline blood pressure, 13 (6.2%) patients
developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%)
patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In
adult patients with MDS with normal baseline blood pressure, 26
(29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients
developed DBP ≥80 mm Hg. Monitor blood pressure prior to each
administration. Manage new or exacerbations of preexisting
hypertension using anti-hypertensive agents.
Embryo-Fetal Toxicity
REBLOZYL may cause fetal harm when administered to a pregnant
woman. REBLOZYL caused increased post-implantation loss, decreased
litter size, and an increased incidence of skeletal variations in
pregnant rat and rabbit studies. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment and for at least 3
months after the final dose.
ADVERSE REACTIONS
Beta-Thalassemia
- Serious adverse reactions occurred in 3.6% of patients on
REBLOZYL. Serious adverse reactions occurring in 1% of patients
included cerebrovascular accident and deep vein thrombosis. A fatal
adverse reaction occurred in 1 patient treated with REBLOZYL who
died due to an unconfirmed case of acute myeloid leukemia
(AML)
- Most common adverse reactions (at least 10% for REBLOZYL and 1%
more than placebo) were headache (26% vs 24%), bone pain (20% vs
8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs
11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and
dizziness (11% vs 5%)
Myelodysplastic
Syndromes
- Grade >3 (≥2%) adverse
reactions included fatigue, hypertension, syncope and
musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%)
patients
- The most common (≥10%) adverse reactions included fatigue,
musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity
reactions, hypertension, headache, upper respiratory tract
infection, bronchitis, and urinary tract infection
LACTATION
It is not known whether REBLOZYL is excreted into human milk or
absorbed systemically after ingestion by a nursing infant. REBLOZYL
was detected in milk of lactating rats. When a drug is present in
animal milk, it is likely that the drug will be present in human
milk. Because many drugs are excreted in human milk, and because of
the unknown effects of REBLOZYL in infants, a decision should be
made whether to discontinue nursing or to discontinue treatment.
Because of the potential for serious adverse reactions in the
breastfed child, breastfeeding is not recommended during treatment
and for 3 months after the last dose.
Please see full Prescribing Information for REBLOZYL.
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
follow us on LinkedIn, Twitter, YouTube, Facebook and
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, that future study results will be consistent with the
results to date, that the product candidates, treatments and
combination treatments described in this release may not receive
regulatory approval for the indications described in this release,
any marketing approvals, if granted, may have significant
limitations on their use, and, if approved, whether such product
candidates, treatments or combination treatments for such
indications described in this release will be commercially
successful. 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.
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