CALQUENCE six-year follow-up data reinforce
long-term benefit in chronic lymphocytic leukemia, and data across
multiple hematology assets showcase breadth of promising early
pipeline
New, longer-term data from ALPHA Phase III
trial will further show potential of danicopan to address
clinically significant extravascular hemolysis and maintain disease
control, allowing paroxysmal nocturnal hemoglobinuria patients to
continue standard-of-care treatment with ULTOMIRIS or
SOLIRIS
AstraZeneca will present new clinical and real-world data in
multiple hematological conditions at the 65th American Society of
Hematology (ASH) Annual Meeting andExposition, December 9 to 12,
2023 in San Diego, CA.
A total of 63 abstracts will feature 14 approved and potential
new medicines across the Company’s portfolio and pipeline including
from Alexion, AstraZeneca’s Rare Disease group, in chronic
lymphocytic leukemia (CLL) and several types of lymphoma,
paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic
uremic syndrome (aHUS) and amyloid light-chain (AL)
amyloidosis.
Anas Younes, Senior Vice President, Hematology R&D,
AstraZeneca, said: “Our data at ASH will exemplify how we are
advancing a range of innovative modalities including antibody drug
conjugates, next-generation immunotherapies and T-cell engagers in
hematology. Updated clinical data for AZD0486, our CD19/CD3 T-cell
engager, reinforce our belief in this approach as a potential new
treatment for lymphoma, and new CALQUENCE data continue to
demonstrate long-term efficacy and safety in chronic lymphocytic
leukemia with further follow up.”
Gianluca Pirozzi, Senior Vice President, Head of Development,
Regulatory and Safety, Alexion, said: “Alexion has transformed the
treatment landscape and redefined care for the paroxysmal nocturnal
hemoglobinuria patient community over the past two decades. At the
ASH Annual Meeting, new results from our pivotal ALPHA trial will
demonstrate the promise of Factor D inhibition to advance care for
the small subset of patients with paroxysmal nocturnal
hemoglobinuria who experience clinically significant extravascular
hemolysis. We are proud to further our leadership in rare disease
by sharing data from our robust hematology pipeline, reflecting our
commitment to innovation and improving outcomes for the patients
and families we serve.”
CALQUENCE® (acalabrutinib) continues to demonstrate
long-term benefits in CLL
Six-year follow-up data from the pivotal ELEVATE-TN Phase III
trial will further support the continued efficacy, safety and
tolerability of CALQUENCE for long-term use in patients with
treatment-naïve CLL.1
Data from a Phase II trial will show the safety and efficacy of
CALQUENCE and rituximab followed by chemotherapy and autologous
stem cell transplantation in fit patients with treatment-naïve
mantle cell lymphoma (MCL).2
An analysis of five prospective CALQUENCE trials, including
three randomized, controlled Phase III trials and two
non-randomized trials, will show acceptable safety outcomes based
on rates of nonfatal and fatal ventricular arrhythmias and sudden
death in patients with CLL.3
Novel early assets show potential to improve outcomes for
blood cancer patients
Data from our early portfolio will demonstrate how the Company
is advancing multiple modalities across several scientific
platforms, including Immuno-Oncology, Immune-Engagers, Antibody
Drug Conjugates (ADCs) and Epigenetics as part of its strategy to
attack cancer from multiple angles.
Updated Phase I data for AstraZeneca’s CD19/CD3 T-cell engager,
AZD0486, will further demonstrate the acceptable safety profile and
high response rate of this treatment in relapsed/refractory (R/R)
B-cell non-Hodgkin lymphoma (NHL).4 We will also present the first
clinical data on sabestomig, a PD-1/TIM-3 targeting bispecific
antibody, in R/R Hodgkin lymphoma, showing encouraging early
signals of activity.5
The first preclinical data for AZD9829, a novel CD123-targeting
ADC, using AstraZeneca’s proprietary linker technology to deliver a
topoisomerase I inhibitor warhead, will demonstrate promising
anti-tumor activity in acute myeloid leukemia.6 In addition,
preclinical data will demonstrate anti-tumor activity of
AstraZeneca’s novel PRMT5 inhibitor in MTAP silenced Hodgkin
lymphoma models.7
Showcasing advances to bolster our leadership in PNH with new
data on Factor D inhibition and impact of C5 inhibition in
long-term disease control
New results from the 24-week and long-term extension period from
the pivotal ALPHA Phase III trial will reinforce the potential for
danicopan add-on therapy to address clinically significant
extravascular hemolysis (EVH) in the small subset of PNH patients
who experience this condition while treated with C5 inhibitor
therapy, allowing them to maintain control of intravascular
hemolysis (IVH) through standard-of-care treatment with ULTOMIRIS®
(ravulizumab-cwvz) or SOLIRIS® (eculizumab).8
Further, patient-reported outcomes from the ALPHA trial will
suggest danicopan as an add-on to ULTOMIRIS or SOLIRIS improved
quality of life compared to C5 inhibitor therapy alone in patients
with PNH who experience clinically significant EVH.9
Additionally, Alexion will present an analysis of six-year
outcomes from the Phase III clinical trial evaluating the safety
and efficacy of ULTOMIRIS in patients with PNH who did not have
previous treatment with a C5 inhibitor.10 The analysis compared
survival against untreated patients in the International PNH
Registry, the largest global real-world database of patients with
PNH. Results will suggest ULTOMIRIS improved survival and
maintained effective long-term control of IVH, the most significant
contributor to morbidity and premature mortality in PNH.10
Improving diagnosis and management of life-threatening rare
diseases, including amyloidosis
24-month results of a Phase II trial will demonstrate the safety
and tolerability of CAEL-101 in combination with
cyclophosphamide-bortezomib-dexamethasone with or without
daratumumab for the treatment of AL amyloidosis.11
Real-world analyses across AL amyloidosis, aHUS and
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) will also be presented, advancing the
scientific understanding of these rare, hematological
conditions.12-16
Key presentations during the 65th ASH Annual Meeting and
Exposition
Lead author
Abstract title
Presentation details
CALQUENCE (acalabrutinib)
Sharman, JP
Acalabrutinib ± Obinutuzumab vs
Obinutuzumab + Chlorambucil in Treatment-naive Chronic Lymphocytic
Leukemia: 6-year Follow-up of ELEVATE-TN
Abstract # 636 Oral Session: 642. Chronic
Lymphocytic Leukemia: Clinical and Epidemiological: Frontline
Treatment with Targeted Agents in Patients with Chronic Lymphocytic
Leukemia December 10, 2023 17:45 PST Location: Seaport Ballroom
ABCD (Manchester Grand Hyatt San Diego)
Westin, J
Smart Stop: Lenalidomide, Tafasitamab,
Rituximab and Acalabrutinib Alone and with Combination Chemotherapy
for the Treatment of Newly Diagnosed Diffuse Large B-cell
Lymphoma
Abstract # 856 Oral Session: 626.
Aggressive Lymphomas: Prospective Therapeutic Trials: Initial
Treatment Strategies in Aggressive B-Cell Lymphomas December 11,
2023 15:30 PST Location: Seaport Ballroom ABCD (Manchester Grand
Hyatt San Diego)
Hawkes, EA
A Window Study of Acalabrutinib and
Rituximab, Followed by Chemotherapy and Autograft (ASCT) in Fit
Patients with Treatment-naïve Mantle Cell Lymphoma (MCL): First
Report of the Investigator-initiated Australasian Leukemia and
Lymphoma Group NHL33 ‘WAMM’ Trial
Abstract # 735 Oral Session: 623. Mantle
Cell, Follicular and Other Indolent B-Cell Lymphomas: Clinical and
Epidemiological: Prospective Clinical Trials in Mantle Cell
Lymphoma Incorporating Novel Agents December 11, 2023 11:00 PST
Location: Grand Hall B (Manchester Grand Hyatt San Diego)
Hawkes, EA
TrAVeRse: A Phase 2, Open-Label,
Randomized Study of Acalabrutinib in Combination with Venetoclax
and Rituximab in Patients with Treatment- naïve Mantle Cell
Lymphoma
Abstract # 3054 Poster Session: 623.
Mantle Cell, Follicular, and Other Indolent B-Cell Lymphomas:
Clinical and Epidemiological: Poster II December 10, 2023 18:00 -
20:00 PST Location: Halls G-H (San Diego Convention Center)
Sharman, J
Analysis of Ventricular Arrhythmias and
Sudden Death with Acalabrutinib From 5 Prospective Clinical
Trials
Abstract # 4643 Poster Session: 642.
Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster
III December 11, 2023 18:00 - 20:00 PST Location: Halls G-H (San
Diego Convention Center)
Ferrajoli, A
Cumulative Review of Hypertension in
Patients with Chronic Lymphocytic Leukemia (CLL) and Other
Hematologic Malignancies Treated with Acalabrutinib: Data from
Clinical Trials
Abstract # 1917 Poster Session: 642.
Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster
I December 9, 2023 17:30 - 19:30 PST Location: Halls G-H (San Diego
Convention Center)
Sun, C
Extended Follow-Up and Resistance
Mutations in CLL Patients Treated with Acalabrutinib
Abstract # 1891 Poster Session: 641.
Chronic Lymphocytic Leukemias: Basic and Translational: Poster I
December 9, 2023 17:30 - 19:30 PST Location: Halls G-H (San Diego
Convention Center)
Jain, P
Acalabrutinib with Rituximab as First-line
Therapy for Older Patients with Mantle Cell Lymphoma – A Phase II
Clinical Trial
Abstract # 3036 Poster Session: 623.
Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas:
Clinical and Epidemiological: Poster II December 10, 2023 18:00 -
20:00 PST Location: Halls G-H (San Diego Convention Center)
Perini, G
ACRUE: A Phase 2, Open-label Study of
Acalabrutinib in Combination with Rituximab in Elderly and/or Frail
Patients with Treatment-naïve Diffuse Large B-Cell Lymphoma
e-Publication Online Only
AZD0486
Gaballa, S
Double Step-Up Dosing (2SUD) Regimen
Mitigates Severe ICANS and CRS While Maintaining a High Efficacy in
Subjects with Relapsed/Refractory (R/R) B-cell Non-Hodgkin Lymphoma
(NHL) Treated with AZD0486, a Novel CD19xCD3 T-cell Engager (TCE):
Updated Safety and Efficacy Data from the Ongoing First-in-Human
(FIH) Phase I Trial
Abstract # 1662 Poster Session: 623.
Mantle Cell, Follicular, and Other Indolent B-Cell Lymphomas:
Clinical and Epidemiological: Poster I December 9, 2023 17:30 -
19:30 PST Location: Halls G-H (San Diego Convention Center)
AZD9829
Dutta, D
First Disclosure of AZD9829, a TOP1i-ADC
Targeting CD123: Promising Preclinical Activity in AML Models with
Minimal Effect on Healthy Progenitors
e-Publication Online Only
AZD7789
Mei, M
Safety and Preliminary Efficacy of
Sabestomig (AZD7789), an Anti-PD-1 and Anti-TIM-3 Bispecific
Antibody, in Patients with Relapsed or Refractory Classical Hodgkin
Lymphoma Previously Treated with Anti-PD-(L)1 Therapy
Abstract # 4433 Poster Session: 624.
Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and
Epidemiological: Poster III December 11, 2023 18:00 - 20:00 PST
Location: Halls G-H (San Diego Convention Center)
PRMT5 inhibitor
Urosevic, J
Epigenetic Silencing of MTAP in Hodgkin’s
Lymphoma Renders it Sensitive to a 2nd Generation PRMT5
Inhibitor
Abstract # 4185 Poster Session: 605.
Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms:
Poster III December 11, 2023 18:00 - 20:00 PST Location: Halls G-H
(San Diego Convention Center)
Danicopan
Kulasekararaj, A
Danicopan as Add-On Therapy to Ravulizumab
or Eculizumab Versus Placebo in Patients with Paroxysmal Nocturnal
Hemoglobinuria and Clinically Significant Extravascular Hemolysis:
Phase 3 Long-term Data
Abstract # 576 Oral Session: 508. Bone
Marrow Failure: Acquired: Unraveling the Future of PNH Therapy from
Clinical Trials December 10, 2023 17:45 PST Location: Room 7 (San
Diego Convention Center)
Piatek, C
Patient-reported Outcomes: Danicopan as
Add-On Therapy to Ravulizumab or Eculizumab Versus Placebo in
Patients with Paroxysmal Nocturnal Hemoglobinuria and Clinically
Significant Extravascular Hemolysis
Abstract # 1346 Poster Session: 508. Bone
Marrow Failure: Acquired: Poster I December 9, 2023 17:30 - 19:30
PST Location: Halls G-H (San Diego Convention Center)
ULTOMIRIS (ravulizumab-cwvz)
Kulasekararaj, A
Ravulizumab Provides Durable Control of
Intravascular Hemolysis and Improves Survival in Patients with
Paroxysmal Nocturnal Hemoglobinuria: Long-Term Follow-Up of Study
301 and Comparisons with Patients of the International PNH
Registry
Abstract # 2714 Poster Session: 508. Bone
Marrow Failure: Acquired: Poster II December 10, 2023 18:00 - 20:00
PST Location: Halls G-H (San Diego Convention Center)
R�th, A
Ravulizumab Effectiveness in the
Real-world: Evidence from the International PNH Registry
Abstract # 2722 Poster Session: 508. Bone
Marrow Failure: Acquired: Poster II December 10, 2023 18:00 - 20:00
PST Location: Halls G-H (San Diego Convention Center)
Piatek, C
Efficacy and Safety of Subcutaneous
Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria
Who Received Prior Intravenous Eculizumab: 2-Year Follow-Up
Abstract # 2713
Poster Session: 508. Bone Marrow Failure:
Acquired: Poster II December 10, 2023 18:00 - 20:00 PST Location:
Halls G-H (San Diego Convention Center)
CAEL-101
Valent, J
Safety and Tolerability of CAEL-101, an
Anti-Amyloid Monoclonal Antibody, Combined with Anti-Plasma Cell
Dyscrasia Therapy in Patients with Light-Chain Amyloidosis:
24-Month Results of a Phase 2 Study
Abstract # 540 Oral Session: 654. MGUS,
Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical
and Epidemiological: From Light Chain to Fibril–Novel Diagnostics
to Treatments for Amyloidosis December 10, 2023 13:15 PST Location:
Seaport Ballroom EFGH (Manchester Grand Hyatt San Diego)
Costello, M
CAEL-101 Enhances the Clearance of Light
Chain Fibrils and Intermediate Aggregates by Phagocytosis
Abstract # 3307 Poster Session: 651.
Multiple Myeloma and Plasma Cell Dyscrasias: Basic and
Translational: Poster II December 10, 2023 18:00 - 20:00 PST
Location: Halls G-H (San Diego Convention Center)
AL Amyloidosis
Lyons, G
Treatment Patterns and Outcomes for
Patients with Light Chain (AL) Amyloidosis: Analysis of a Large US
Claims Database
e-Publication Online Only
Thompson, J
Real-world Treatment Patterns Following
Update to National Comprehensive Cancer Network Guidelines for
Light-Chain Amyloidosis: Results from a US Administrative Claims
Database
e-Publication Online Only
Laires, P
Prevalence, Incidence, and
Characterization of Light Chain Amyloidosis in the USA: A
Real-world Analysis Utilizing Electronic Health Records (EHR)
e-Publication Online Only
aHUS
Wang, Y
Patient Characteristics and Diagnostic
Journey of Thrombotic Microangiopathy Associated with a Trigger: A
Real-world, Retrospective, Multi-national Study
e-Publication Online Only
HSCT-TMA
Wang, Y
Real-World Analysis of the Underdiagnosis,
Clinical Outcomes and Associated Burden of Hematopoietic Stem Cell
Transplantation-Associated Thrombotic Microangiopathy (HSCT-TMA) in
the United States of America
Abstract # 491 Oral Session: 904. Outcomes
Research – Non-Malignant Conditions: What to Know: Management Costs
and Outcomes in Various Non-Malignant Disorders December 10, 2023
10:30 PST Location: Pacific Ballroom Salons 15-17 (Marriott Marquis
San Diego Marina)
PNH
Wagner-Ballon, O
Neutrophil PNH Type II Cells Are
Associated with Thrombosis and Bone Marrow Failure Without
Hemolysis: Evidence from Analysis of the 5-year French Nation-Wide
Multicenter Observational Study
Abstract # 4083 Poster Session: 508. Bone
Marrow Failure: Acquired: Poster III December 11, 2023 18:00 -
20:00 PST Location: Halls G-H (San Diego Convention Center)
INDICATIONS AND USAGE
CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated
for the treatment of adult patients with mantle cell lymphoma (MCL)
who have received at least one prior therapy.
This indication is approved under accelerated approval based on
overall response rate. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in confirmatory trials.
CALQUENCE is also indicated for the treatment of adult patients
with chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL).
IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib)
tablets
Serious and Opportunistic Infections
Fatal and serious infections, including opportunistic
infections, have occurred in patients with hematologic malignancies
treated with CALQUENCE.
Serious or Grade 3 or higher infections (bacterial, viral, or
fungal) occurred in 19% of 1029 patients exposed to CALQUENCE in
clinical trials, most often due to respiratory tract infections
(11% of all patients, including pneumonia in 6%). These infections
predominantly occurred in the absence of Grade 3 or 4 neutropenia,
with neutropenic infection reported in 1.9% of all patients.
Opportunistic infections in recipients of CALQUENCE have included,
but are not limited to, hepatitis B virus reactivation, fungal
pneumonia, Pneumocystis jirovecii pneumonia, Epstein-Barr virus
reactivation, cytomegalovirus, and progressive multifocal
leukoencephalopathy (PML). Consider prophylaxis in patients who are
at increased risk for opportunistic infections. Monitor patients
for signs and symptoms of infection and treat promptly.
Hemorrhage
Fatal and serious hemorrhagic events have occurred in patients
with hematologic malignancies treated with CALQUENCE. Major
hemorrhage (serious or Grade 3 or higher bleeding or any central
nervous system bleeding) occurred in 3.0% of patients, with fatal
hemorrhage occurring in 0.1% of 1029 patients exposed to CALQUENCE
in clinical trials. Bleeding events of any grade, excluding
bruising and petechiae, occurred in 22% of patients.
Use of antithrombotic agents concomitantly with CALQUENCE may
further increase the risk of hemorrhage. In clinical trials, major
hemorrhage occurred in 2.7% of patients taking CALQUENCE without
antithrombotic agents and 3.6% of patients taking CALQUENCE with
antithrombotic agents. Consider the risks and benefits of
antithrombotic agents when co-administered with CALQUENCE. Monitor
patients for signs of bleeding.
Consider the benefit-risk of withholding CALQUENCE for 3-7 days
pre- and post-surgery depending upon the type of surgery and the
risk of bleeding.
Cytopenias
Grade 3 or 4 cytopenias, including neutropenia (23%), anemia
(8%), thrombocytopenia (7%), and lymphopenia (7%), developed in
patients with hematologic malignancies treated with CALQUENCE.
Grade 4 neutropenia developed in 12% of patients. Monitor complete
blood counts regularly during treatment. Interrupt treatment,
reduce the dose, or discontinue treatment as warranted.
Second Primary Malignancies
Second primary malignancies, including skin cancers and other
solid tumors, occurred in 12% of 1029 patients exposed to CALQUENCE
in clinical trials. The most frequent second primary malignancy was
skin cancer, reported in 6% of patients. Monitor patients for skin
cancers and advise protection from sun exposure.
Atrial Fibrillation and Flutter
Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029
patients treated with CALQUENCE, with all grades of atrial
fibrillation or flutter reported in 4.1% of all patients. The risk
may be increased in patients with cardiac risk factors,
hypertension, previous arrhythmias, and acute infection. Monitor
for symptoms of arrhythmia (eg, palpitations, dizziness, syncope,
dyspnea) and manage as appropriate.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) of any grade in
patients with relapsed or refractory MCL were anemia,*
thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%),
fatigue (28%), myalgia (21%), and bruising (21%). The most common
Grade ≥3 non-hematological adverse reaction (reported in at least
2% of patients) was diarrhea (3.2%).
*Treatment-emergent decreases (all grades) of hemoglobin (46%),
platelets (44%), and neutrophils (36%) were based on laboratory
measurements and adverse reactions.
Dose reductions or discontinuations due to any adverse reaction
were reported in 1.6% and 6.5% of patients, respectively. Increases
in creatinine to 1.5 to 3 times the upper limit of normal (ULN)
occurred in 4.8% of patients.
The most common adverse reactions (≥30%) of any grade in
patients with CLL were anemia,* neutropenia,* thrombocytopenia,*
headache, upper respiratory tract infection, and diarrhea.
*Treatment-emergent decreases (all grades) of hemoglobin,
platelets, and neutrophils were based on laboratory measurements
and adverse reactions.
In patients with previously untreated CLL exposed to CALQUENCE,
fatal adverse reactions that occurred in the absence of disease
progression and with onset within 30 days of the last study
treatment were reported in 2% for each treatment arm, most often
from infection. Serious adverse reactions were reported in 39% of
patients in the CALQUENCE plus obinutuzumab arm and 32% in the
CALQUENCE monotherapy arm, most often due to events of pneumonia
(7% and 2.8%, respectively).
Adverse reactions led to CALQUENCE dose reduction in 7% and 4%
of patients in the CALQUENCE plus obinutuzumab arm (N=178) and
CALQUENCE monotherapy arm (N=179), respectively. Adverse events led
to discontinuation in 11% and 10% of patients, respectively.
Increases in creatinine to 1.5 to 3 times ULN occurred in 3.9% and
2.8% of patients in the CALQUENCE combination arm and monotherapy
arm, respectively.
In patients with relapsed/refractory CLL exposed to CALQUENCE,
serious adverse reactions occurred in 29% of patients. Serious
adverse reactions in >5% of patients who received CALQUENCE
included lower respiratory tract infection (6%). Fatal adverse
reactions within 30 days of the last dose of CALQUENCE occurred in
2.6% of patients, including from second primary malignancies and
infection.
Adverse reactions led to CALQUENCE dose reduction in 3.9% of
patients (N=154), dose interruptions in 34% of patients, most often
due to respiratory tract infections followed by neutropenia, and
discontinuation in 10% of patients, most frequently due to second
primary malignancies followed by infection. Increases in creatinine
to 1.5 to 3 times ULN occurred in 1.3% of patients who received
CALQUENCE.
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid co-administration of
CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will
be used short-term, interrupt CALQUENCE. After discontinuation of
strong CYP3A inhibitor for at least 24 hours, resume previous
dosage of CALQUENCE.
Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE
to 100 mg once daily when co-administered with a moderate CYP3A
inhibitor.
Strong CYP3A Inducers: Avoid co-administration of
CALQUENCE with a strong CYP3A inducer. If co-administration is
unavoidable, increase the dosage of CALQUENCE to 200 mg
approximately every 12 hours.
SPECIFIC POPULATIONS
Based on findings in animals, CALQUENCE may cause fetal harm and
dystocia when administered to a pregnant woman. There are no
available data in pregnant women to inform the drug-associated
risk. Advise pregnant women of the potential risk to a fetus.
Pregnancy testing is recommended for females of reproductive
potential prior to initiating CALQUENCE therapy. Advise female
patients of reproductive potential to use effective contraception
during treatment with CALQUENCE and for 1 week following the last
dose of CALQUENCE.
It is not known if CALQUENCE is present in human milk. Advise
lactating women not to breastfeed while taking CALQUENCE and for 2
weeks after the last dose.
Avoid use of CALQUENCE in patients with severe hepatic
impairment (Child-Pugh class C). No dosage adjustment of CALQUENCE
is recommended in patients with mild (Child-Pugh class A) or
moderate (Child-Pugh class B) hepatic impairment.
Please see full Prescribing Information,
including Patient Information.
INDICATION(S) & IMPORTANT SAFETY INFORMATION for
ULTOMIRIS® (ravulizumab-cwvz)
What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine used to treat:
- adults and children 1 month of age and older with a disease
called Paroxysmal Nocturnal Hemoglobinuria (PNH).
- adults and children 1 month of age and older with a disease
called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not
used in treating people with Shiga toxin E. coli related hemolytic
uremic syndrome (STEC-HUS).
- adults with a disease called generalized Myasthenia Gravis
(gMG) who are anti-acetylcholine receptor (AChR) antibody
positive.
- adults with PNH or aHUS when administered subcutaneously (under
your skin).
It is not known if ULTOMIRIS is safe and effective in children
younger than 1 month of age.
It is not known if ULTOMIRIS is safe and effective for the
treatment of gMG in children.
Subcutaneous administration of ULTOMIRIS has not been evaluated
and is not approved for use in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and
can lower the ability of your immune system to fight
infections.
- ULTOMIRIS increases your chance of getting serious and
life-threatening meningococcal infections that may quickly become
life-threatening and cause death if not recognized and treated
early.
- You must receive meningococcal vaccines at least 2 weeks before
your first dose of ULTOMIRIS if you are not vaccinated.
- If your healthcare provider decided that urgent treatment with
ULTOMIRIS is needed, you should receive meningococcal vaccination
as soon as possible.
- If you have not been vaccinated and ULTOMIRIS therapy must be
initiated immediately, you should also receive 2 weeks of
antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need
additional vaccination. Your healthcare provider will decide if you
need additional vaccination.
- Meningococcal vaccines reduce but do not prevent all
meningococcal infections. Call your healthcare provider or get
emergency medical care right away if you get any of these signs and
symptoms of a meningococcal infection: headache with nausea or
vomiting, headache and fever, headache with a stiff neck or stiff
back, fever, fever and a rash, confusion, muscle aches with
flu-like symptoms and eyes sensitive to light.
Your healthcare provider will give you a Patient Safety Card
about the risk of meningococcal infection. Carry it with you at
all times during treatment and for 8 months after your last
ULTOMIRIS dose. It is important to show this card to any healthcare
provider or nurse to help them diagnose and treat you quickly.
ULTOMIRIS is only available through a program called the
ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your
healthcare provider must: enroll in the ULTOMIRIS REMS program;
counsel you about the risk of meningococcal infection; give you
information and a Patient Safety Card about the symptoms and your
risk of meningococcal infection (as discussed above); and make sure
that you are vaccinated with a meningococcal vaccine, and if
needed, get revaccinated with the meningococcal vaccine. Ask your
healthcare provider if you are not sure if you need to be
revaccinated.
ULTOMIRIS may also increase the risk of other types of
serious infections. Make sure your child receives vaccinations
against Streptococcus pneumoniae and Haemophilus influenzae type b
(Hib) if treated with ULTOMIRIS. Call your healthcare provider
right away if you have any new signs or symptoms of infection.
Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a meningococcal
infection or have not been vaccinated against meningococcal
infection unless your healthcare provider decides that urgent
treatment with ULTOMIRIS is needed.
Before you receive ULTOMIRIS, tell your healthcare provider
about all of your medical conditions, including if you: have an
infection or fever, are pregnant or plan to become pregnant, and
are breastfeeding or plan to breastfeed. It is not known if
ULTOMIRIS will harm your unborn baby or if it passes into your
breast milk. You should not breastfeed during treatment and for 8
months after your final dose of ULTOMIRIS.
Tell your healthcare provider about all the vaccines you
receive and medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements which
could affect your treatment.
If you have PNH and you stop receiving ULTOMIRIS, your
healthcare provider will need to monitor you closely for at least
16 weeks after you stop ULTOMIRIS. Stopping ULTOMIRIS may cause
breakdown of your red blood cells due to PNH. Symptoms or problems
that can happen due to red blood cell breakdown include: drop
in your red blood cell count, tiredness, blood in your urine,
stomach-area (abdomen) pain, shortness of breath, blood clots,
trouble swallowing, and erectile dysfunction (ED) in males.
If you have aHUS, your healthcare provider will need to
monitor you closely for at least 12 months after stopping treatment
for signs of worsening aHUS or problems related to a type of
abnormal clotting and breakdown of your red blood cells called
thrombotic microangiopathy (TMA). Symptoms or problems that can
happen with TMA may include: confusion or loss of
consciousness, seizures, chest pain (angina), difficulty breathing
and blood clots or stroke.
ULTOMIRIS can cause serious side effects including allergic
reactions to acrylic adhesive. Allergic reactions to the
acrylic adhesive may happen with your subcutaneous ULTOMIRIS
treatment. If you have an allergic reaction during the delivery of
subcutaneous ULTOMIRIS, remove the on-body injector and get medical
help right away. Your healthcare provider may treat you with
medicines to help prevent or treat allergic reaction symptoms as
needed.
What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including
infusion-related reactions. Symptoms of an infusion-related
reaction with ULTOMIRIS may include lower back pain, tiredness,
feeling faint, discomfort in your arms or legs, bad taste, or
drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare
provider or nurse right away if you develop these symptoms, or any
other symptoms during your ULTOMIRIS infusion that may mean you are
having a serious infusion reaction, including: chest pain, trouble
breathing or shortness of breath, swelling of your face, tongue, or
throat, and feel faint or pass out.
The most common side effects of ULTOMIRIS in people treated
for PNH are upper respiratory tract infection and headache.
The most common side effects of ULTOMIRIS in people treated
for aHUS are upper respiratory tract infection, diarrhea, nausea,
vomiting, headache, high blood pressure and fever.
The most common side effects of ULTOMIRIS in people with gMG
are diarrhea and upper respiratory tract infections.
The most common side effects of subcutaneous administration
of ULTOMIRIS in adults treated for PNH and aHUS are local injection
site reactions.
Tell your healthcare provider about any side effect that bothers
you or that does not go away. These are not all the possible side
effects of ULTOMIRIS. For more information, ask your healthcare
provider or pharmacist. Call your healthcare provider right away if
you miss an ULTOMIRIS infusion or for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Instructions for Use that comes with subcutaneous
ULTOMIRIS for instructions about the right way to prepare and give
your subcutaneous ULTOMIRIS injections through an on-body
injector.
Please see the accompanying full Prescribing
Information and Medication Guide for
ULTOMIRIS, including Boxed WARNING regarding serious and
life-threatening meningococcal infections/sepsis. Please see the
accompanying Instructions for Use for the ULTOMIRIS On Body
Delivery System.
INDICATIONS & IMPORTANT SAFETY INFORMATION FOR SOLIRIS®
(eculizumab) [injection for intravenous use 300mg/30mL
vial]
What is SOLIRIS?
SOLIRIS is a prescription medicine used to treat:
- patients with a disease called Paroxysmal Nocturnal
Hemoglobinuria (PNH).
- adults and children with a disease called atypical Hemolytic
Uremic Syndrome (aHUS). SOLIRIS is not for use in treating people
with Shiga toxin E. coli related hemolytic uremic syndrome
(STEC-HUS).
- adults with a disease called generalized myasthenia gravis
(gMG) who are anti-acetylcholine receptor (AChR) antibody
positive.
- adults with a disease called neuromyelitis optica spectrum
disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody
positive.
It is not known if SOLIRIS is safe and effective in children
with PNH, gMG, or NMOSD.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
SOLIRIS?
SOLIRIS is a medicine that affects your immune system and can
lower the ability of your immune system to fight
infections.
- SOLIRIS increases your chance of getting serious and
life-threatening meningococcal infections that may quickly become
life-threatening and cause death if not recognized and treated
early.
- You must receive meningococcal vaccines at least 2 weeks before
your first dose of SOLIRIS if you are not vaccinated.
- If your doctor decided that urgent treatment with SOLIRIS is
needed, you should receive meningococcal vaccination as soon as
possible.
- If you have not been vaccinated and SOLIRIS therapy must be
initiated immediately, you should also receive 2 weeks of
antibiotics with your vaccinations.
- If you had a meningococcal vaccine in the past, you might need
additional vaccination. Your doctor will decide if you need
additional vaccination.
- Meningococcal vaccines reduce but do not prevent all
meningococcal infections. Call your doctor or get emergency medical
care right away if you get any of these signs and symptoms of a
meningococcal infection: headache with nausea or vomiting, headache
and fever, headache with a stiff neck or stiff back, fever, fever
and a rash, confusion, muscle aches with flu-like symptoms, and
eyes sensitive to light.
Your doctor will give you a Patient Safety Card about the
risk of meningococcal infection. Carry it with you at all times
during treatment and for 3 months after your last SOLIRIS dose. It
is important to show this card to any doctor or nurse to help them
diagnose and treat you quickly.
SOLIRIS is only available through a program called the
SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must
enroll in the SOLIRIS REMS program; counsel you about the risk of
meningococcal infection; give you information and a Patient
Safety Card about the symptoms and your risk of meningococcal
infection (as discussed above); and make sure that you are
vaccinated with the meningococcal vaccine and, if needed, get
revaccinated with the meningococcal vaccine. Ask your doctor if you
are not sure if you need to be revaccinated.
SOLIRIS may also increase the risk of other types of serious
infections. Make sure your child receives vaccinations against
Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if
treated with SOLIRIS. Certain people may be at risk of serious
infections with gonorrhea. Certain fungal infections (Aspergillus)
may occur if you take SOLIRIS and have a weak immune system or a
low white blood cell count.
Who should not receive SOLIRIS?
Do not receive SOLIRIS if you have a meningococcal infection
or have not been vaccinated against meningitis infection unless
your doctor decides that urgent treatment with SOLIRIS is
needed.
Before you receive SOLIRIS, tell your doctor about all of
your medical conditions, including if you: have an infection or
fever, are pregnant or plan to become pregnant, and are
breastfeeding or plan to breastfeed. It is not known if SOLIRIS
will harm your unborn baby or if it passes into your breast
milk.
Tell your doctor about all the vaccines you receive and
medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements which could affect your
treatment. It is important that you have all recommended
vaccinations before you start SOLIRIS, receive 2 weeks of
antibiotics if you immediately start SOLIRIS, and stay up-to-date
with all recommended vaccinations during treatment with
SOLIRIS.
If you have PNH, your doctor will need to monitor you closely
for at least 8 weeks after stopping SOLIRIS. Stopping treatment
with SOLIRIS may cause breakdown of your red blood cells due to
PNH. Symptoms or problems that can happen due to red blood cell
breakdown include: drop in the number of your red blood cell count,
drop in your platelet count, confusion, kidney problems, blood
clots, difficulty breathing, and chest pain.
If you have aHUS, your doctor will need to monitor you
closely during and for at least 12 weeks after stopping treatment
for signs of worsening aHUS symptoms or problems related to
abnormal clotting (thrombotic microangiopathy). Symptoms or
problems that can happen with abnormal clotting may include:
stroke, confusion, seizure, chest pain (angina), difficulty
breathing, kidney problems, swelling in arms or legs, and a drop in
your platelet count.
What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including serious
infusion-related reactions. Tell your doctor or nurse right
away if you get any of these symptoms during your SOLIRIS infusion:
chest pain; trouble breathing or shortness of breath; swelling of
your face, tongue, or throat; and feel faint or pass out. If you
have an infusion-related reaction to SOLIRIS, your doctor may need
to infuse SOLIRIS more slowly, or stop SOLIRIS.
The most common side effects in people with PNH treated with
SOLIRIS include: headache, pain or swelling of your nose or
throat (nasopharyngitis), back pain, and nausea.
The most common side effects in people with aHUS treated with
SOLIRIS include: headache, diarrhea, high blood pressure
(hypertension), common cold (upper respiratory infection),
stomach-area (abdominal) pain, vomiting, pain or swelling of your
nose or throat (nasopharyngitis), low red blood cell count
(anemia), cough, swelling of legs or feet (peripheral edema),
nausea, urinary tract infections, and fever.
The most common side effects in people with gMG treated with
SOLIRIS include: muscle and joint (musculoskeletal) pain.
The most common side effects in people with NMOSD treated
with SOLIRIS include: common cold (upper respiratory
infection); pain or swelling of your nose or throat
(nasopharyngitis); diarrhea; back pain; dizziness; flu-like
symptoms (influenza), including fever, headache, tiredness, cough,
sore throat, and body aches; joint pain (arthralgia); throat
irritation (pharyngitis); and bruising (contusion).
Tell your doctor about any side effect that bothers you or that
does not go away. These are not all the possible side effects of
SOLIRIS. For more information, ask your doctor or pharmacist. Call
your doctor for medical advice about side effects. You are
encouraged to report negative side effects of prescription drugs to
the FDA. Visit MedWatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information
and Medication Guide for SOLIRIS, including Boxed
WARNING regarding serious and life-threatening meningococcal
infections.
Notes
CALQUENCE® (acalabrutinib)
CALQUENCE® (acalabrutinib) is a next-generation,
selective inhibitor of Bruton’s tyrosine kinase (BTK). CALQUENCE
binds covalently to BTK, thereby inhibiting its activity.17,18 In B
cells, BTK signaling results in activation of pathways necessary
for B-cell proliferation, trafficking, chemotaxis and adhesion.
CALQUENCE has been used to treat 50,000 patients worldwide and
is approved in the US for the treatment of CLL and SLL and for the
treatment of adult patients with MCL who have received at least one
prior therapy.17 CALQUENCE is approved for CLL in the EU and many
other countries worldwide and approved in Japan for relapsed or
refractory CLL and SLL.
As part of an extensive clinical development program,
AstraZeneca is currently evaluating CALQUENCE in more than 20
company-sponsored clinical trials. CALQUENCE is being evaluated for
the treatment of multiple B-cell blood cancers, including CLL, MCL,
diffuse large B-cell lymphoma, Waldenstr�m’s macroglobulinemia,
marginal zone lymphoma and other hematologic malignancies.
ULTOMIRIS® (ravulizumab-cwvz)
ULTOMIRIS® (ravulizumab-cwvz), the first and only long-acting C5
complement inhibitor, provides immediate, complete and sustained
complement inhibition. The medication works by inhibiting the C5
protein in the terminal complement cascade, a part of the body’s
immune system. When activated in an uncontrolled manner, the
complement cascade over-responds, leading the body to attack its
own healthy cells. ULTOMIRIS is administered intravenously every
eight weeks in adult patients, following a loading dose.
ULTOMIRIS is approved in the US, EU and Japan for the treatment
of certain adults with generalized myasthenia gravis (gMG).
ULTOMIRIS is also approved in the US, EU and Japan for the
treatment of certain adults with PNH and for certain children with
PNH in the US and EU.
Additionally, ULTOMIRIS is approved in the US, EU and Japan for
certain adults and children with aHUS to inhibit
complement-mediated thrombotic microangiopathy.
Further, ULTOMIRIS is approved in the EU and Japan for the
treatment of certain adults with neuromyelitis optica spectrum
disorder (NMOSD).
As part of a broad development program, ULTOMIRIS is being
assessed for the treatment of additional hematology and neurology
indications.
SOLIRIS® (eculizumab)
SOLIRIS® (eculizumab) is a first-in-class C5 complement
inhibitor. The medication works by inhibiting the C5 protein in the
terminal complement cascade, a part of the body’s immune system.
When activated in an uncontrolled manner, the terminal complement
cascade over-responds, leading the body to attack its own healthy
cells. SOLIRIS is administered intravenously every two weeks,
following an introductory dosing period.
SOLIRIS is approved in the US, EU, Japan and China for the
treatment of patients with PNH and aHUS.
Additionally, SOLIRIS is approved in Japan and the EU for the
treatment of certain adult and pediatric patients with gMG and in
the US and China for certain adults with gMG.
Further, SOLIRIS is approved in the US, EU, Japan and China for
the treatment of certain adults with NMOSD.
SOLIRIS is not indicated for the treatment of patients with
Shiga-toxin E. coli-related hemolytic uremic syndrome.
AstraZeneca in hematology
AstraZeneca is pushing the boundaries of science to redefine
care in hematology. We have expanded our commitment to patients
with hematologic conditions, not only in oncology but also in rare
diseases with the acquisition of Alexion, allowing us to reach more
patients with high unmet needs. By applying our deep understanding
of blood cancers, leveraging our strength in solid tumor oncology
and delivering on Alexion’s pioneering legacy in complement science
to provide innovative medicines for rare diseases, we are pursuing
the end-to-end development of novel therapies designed to target
underlying drivers of disease.
By targeting hematologic conditions with high unmet medical
needs, we aim to deliver innovative medicines and approaches to
improve patient outcomes. Our goal is to help transform the lives
of patients living with malignant, rare and other related
hematologic diseases, shaped by insights from patients, caregivers
and physicians to have the most meaningful impact.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyze changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
Alexion
Alexion, AstraZeneca Rare Disease, is the group within
AstraZeneca focused on rare diseases, created following the 2021
acquisition of Alexion Pharmaceuticals, Inc. As a leader in rare
diseases for more than 30 years, Alexion is focused on serving
patients and families affected by rare diseases and devastating
conditions through the discovery, development and commercialization
of life-changing medicines. Alexion focuses its research efforts on
novel molecules and targets in the complement cascade and its
development efforts on hematology, nephrology, neurology, metabolic
disorders, cardiology and ophthalmology. Headquartered in Boston,
Massachusetts, Alexion has offices around the globe and serves
patients in more than 50 countries.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialization of prescription medicines in
Oncology, Rare Diseases and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit www.astrazeneca-us.com and follow
the Company on social media @AstraZenecaUS.
References
- Sharman JP, Egyed M, Jurczak J, et al. Acalabrutinib ±
Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-naive
Chronic Lymphocytic Leukemia: 6-year Follow-up of ELEVATE-TN.
Presented at: American Society of Hematology (ASH) Annual Meeting
and Exposition 2023; December 9-12, 2023; San Diego, CA. Abs
636.
- Hawkes EA, Lee ST, Churilov L, et al. A Window Study of
Acalabrutinib, Rituximab, Followed by Chemotherapy and Autograft
(ASCT) in Fit Patients with Treatment-naïve Mantle Cell Lymphoma
(MCL): The Investigator-led Australasian Leukemia and Lymphoma
Group NHL33 ‘WAMM’ Trial. Presented at: American Society of
Hematology (ASH) Annual Meeting and Exposition 2023; December 9-12,
2023; San Diego, CA. Abs 735.
- Sharman JP, Ghia P, Miranda P, et al. Analysis of Ventricular
Arrhythmias and Sudden Death with Acalabrutinib From 5 Prospective
Clinical Trials. Presented at: American Society of Hematology (ASH)
Annual Meeting and Exposition 2023; December 9-12, 2023; San Diego,
CA. Abs 4643.
- Gaballa S, Nair R, Jacobs R, et al. Double step-up dosing
(2SUD) regimen mitigates severe ICANS and CRS while maintaining
high efficacy in subjects with relapsed/refractory (R/R) B-cell
Non-Hodgkin Lymphoma (NHL) Treated with AZD0486, a Novel CD19xCD3
T-cell Engager (TCE): Updated Safety and Efficacy data from the
Ongoing First-in-human (FIH) Phase 1 trial. Presented at: American
Society of Hematology (ASH) Annual Meeting and Exposition 2023;
December 9-12, 2023; San Diego, CA. Abs 1662.
- Mei M, Corazzelli G, Morschhauser F, et al. Safety and
Preliminary Efficacy of Sabestomig (AZD7789), an Anti-PD-1 and
Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or
Refractory Classical Hodgkin Lymphoma Previously Treated with
Anti-PD-(L)1 Therapy. Presented at: American Society of Hematology
(ASH) Annual Meeting and Exposition 2023; December 9-12, 2023; San
Diego, CA. Abs 4433.
- Dutta D, Pan P, Fleming R, et al. First Disclosure of AZD9829,
a TOP1i-ADC Targeting CD123: Promising Preclinical Activity in AML
Models with Minimal Effect on Healthy Progenitors. Presented at
American Society of Hematology (ASH) Annual Meeting and Exposition
2023; December 9-12, 2023; San Diego, California.
e-Publication.
- Urosevic J, Lynch JT, Meyer S, et al. Epigenetic Silencing of
MTAP in Hodgkin’s Lymphoma Renders it Sensitive to a 2nd Generation
PRMT5 Inhibitor. Presented at: American Society of Hematology (ASH)
Annual Meeting and Exposition 2023; December 9-12, 2023; San Diego,
CA. Abs 4185.
- Kulasekararaj A, Griffin M, Piatek CI, et al. Danicopan as
Add-on Therapy to Ravulizumab or Eculizumab Versus Placebo in
Patients with Paroxysmal Nocturnal Hemoglobinuria and Clinically
Significant Extravascular Hemolysis: Phase 3 Long-term Data.
Presented at: American Society of Hematology (ASH) Congress;
December 9-12, 2023; San Diego, CA. Abs 576.
- Piatek C, et al. Patient-Reported Outcomes: Danicopan as Add-On
Therapy to Ravulizumab or Eculizumab Versus Placebo in Patients
with Paroxysmal Nocturnal Hemoglobinuria and Clinically Significant
Extravascular Hemolysis. Presented at: American Society of
Hematology (ASH) Congress; December 9-12, 2023; San Diego, CA. Abs
1346.
- Kulasekararaj A, Schrezenmeier H, Usuki K, et al. Ravulizumab
Provides Durable Control of Intravascular Hemolysis and Improves
Survival in Patients with Paroxysmal Nocturnal Hemoglobinuria:
Long-term Follow-up of Study 301 and Comparisons with Patients of
the International PNH Registry. Presented at: American Society of
Hematology (ASH) Congress; December 9-12, 2023; San Diego, CA. Abs
2714.
- Valent J, Liedtke M, Zonder JA, et al. Safety and Tolerability
of CAEL-101, an Anti-Amyloid Monoclonal Antibody, Combined with
Anti-Plasma Cell Dyscrasia Therapy in Patients with Light-Chain
Amyloidosis: 24-Month Results of a Phase 2 Study. Presented at:
American Society of Hematology (ASH) Congress; December 9-12, 2023;
San Diego, CA. Abs 540.
- Lyons G, et al. Treatment Patterns and Outcomes for Patients
with Light Chain (AL) Amyloidosis: Analysis of a Large US Claims
Database. Presented at: American Society of Hematology (ASH)
Congress; December 9-12, 2023; San Diego, CA.
- Thompson J, et al. Real-world Treatment Patterns Following
Update to National Comprehensive Cancer Network Guidelines for
Light-Chain Amyloidosis: Results from a US Administrative Claims
Database. Presented at: American Society of Hematology (ASH)
Congress; December 9-12, 2023; San Diego, CA.
- Laires P, et al. Prevalence, Incidence, and Characterization of
Light Chain Amyloidosis in the USA: A Real-world Analysis Utilizing
Electronic Health Records (EHR). Presented at: American Society of
Hematology (ASH) Congress; December 9-12, 2023; San Diego, CA.
- Wang Y, et al. Patient Characteristics and Diagnostic Journey
of Thrombotic Microangiopathy Associated with a Trigger: A
Real-world, Retrospective, Multi-National Study. Presented at:
American Society of Hematology (ASH) Congress; December 9-12, 2023;
San Diego, CA.
- Wang Y, Rava A, Smuzynski M, et al. Real-world Analysis of the
Underdiagnosis, Clinical Outcomes and Associated Burden of
Hematopoietic Stem Cell Transplantation-associated Thrombotic
Microangiopathy (HSCT-TMA) in the United States of America.
Presented at: American Society of Hematology (ASH) Congress;
December 9-12, 2023; San Diego, CA. Abs 491.
- CALQUENCE® (acalabrutinib) [prescribing information].
Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2022.
- Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective
second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).
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Media Inquiries Brendan McEvoy +1 302 885 2677 Miranda
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