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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received approval from the FDA on November 6,
2025, for the treatment of adult patients with high-risk smoldering multiple myeloma (SMM) as monotherapy
based on the AQUILA trial.1
AQUILA(NCT03301220) was a phase 3, open-label, randomized trial that evaluated the safety
and efficacy of DARZALEX FASPRO® monotherapy vs active monitoring in patients with high-risk
smoldering multiple myeloma.1,2
AQUILA high-risk definition
The AQUILA high-risk eligibility criteria were based on a compilation
of risk models that were recognized at the time AQUILA was designed in 2015 and
consistent with the 2015 consensus model.3 The table below provides a summary of
which high-risk parameters utilized by existing models at the time of AQUILA study
design were used in the study.
AQUILA risk factors2
Mayo (2008)4
PETHEMA (2007)5
Other risk factors3,6
2015 consensus model for high- risk SMM3
BMPCs ≥10%
X
X
And ≥1 of the following:
Serum M-protein ≥30 g/L
X
X
Abnormal FLC ratio ≥8 and <100 (serum involved:uninvolved)
X
X
IgA SMM
X
X
Immunoparesis with reduction of 2 uninvolved Ig isotypes
X
X
Clonal BMPCs >50% to <60%
X
X
Updates to high-risk definition
After AQUILA began enrolling patients in 2017, different models for
identifying patients with high-risk SMM have been established, particularly the Mayo
2018 criteria.7 While there is other criteria, such as IMWG scoring system8 and
PANGEA 2023,9 Mayo 2018 criteria is currently the most widely accepted by
physicians.
The table below provides a comparison of the AQUILA high-risk
eligibility criteria to the Mayo 2018 criteria.
AQUILA2
Mayo 2018 20/2/207
Clonal BMPCs ≥10% AND ≥1 risk factors:
Serum M-protein ≥30 g/L
IgA SMM
Immunoparesis with reduction of 2 uninvolved Ig isotypes (IgA, IgM, or
IgG only)
FLC ratio ≥8 to <100
Clonal BMPCs >50% to <60% with measurable disease
Genetic modifications (t[4;14], t[14;16], del[17p], and/or amp[1q21])
will be investigated as an exploratory objective
≥2 risk factors:
BMPCs >20%
M-protein >2 g/dL
FLC ratio >20
41%
of AQUILA patients exhibited ≥2 of the Mayo 2018 criteria for high-risk
SMM.2
DARZALEX FASPRO® is only indicated for patients with high-risk SMM.
It is not indicated for other risk categories.1
Key eligibility2
≥18 years of age
Confirmed SMM diagnosis (per IMWG criteria) for ≤5 years
ECOG PS score of 0 or 1
Clonal BMPCs ≥10% and ≥1 of the following risk factors:
Serum M-protein ≥30 g/L
IgA SMM
Immunoparesis with reduction of 2 uninvolved Ig isotypes
Serum involved:uninvolved FLC ratio ≥8 and <100
Clonal BMPCs >50% to <60%
All patients were required to have CT/PET-CT and MRI imaging during
screening10
Stratification factors2
Number of risk factors associated with progression to MM (<3 vs ≥3)
Serum M-protein level ≥30 g/L (yes vs no)
IgA SMM (yes vs no)
Degree of immunoparesis (reduced levels of 2 uninvolved immunoglobulins vs
reduced levels of <2 uninvolved immunoglobulins)
Serum FLC ratio ≥8 (yes vs no)
Percentage of clonal plasma cells in bone marrow (>50% to <60% vs ≤50%)
The criteria defining high-risk SMM have evolved over the years and differ among studies
of interest for the treatment of this disease, highlighting a need for more uniform
criteria2
In AQUILA, the criteria for high-risk SMM were based on data available at the time
of trial development, before the establishment of Mayo 2018 risk criteria
Objective: To evaluate the efficacy and safety of DARZALEX
FASPRO® monotherapy vs active monitoring in patients with high-risk smoldering
myeloma.1,2
The criteria defining high-risk smoldering multiple myeloma have evolved
over the years and differ among studies of interest for the treatment of
this disease, highlighting a need for more uniform criteria
In AQUILA, the criteria for high-risk smoldering multiple myeloma were
based on data available at the time of trial development before the
establishment of Mayo 2018 risk criteria
In accordance with the Mayo 2018 risk criteria, 41% of patients
were retrospectively classified as having high-risk disease
Various subsequent therapies were initiated at the time of disease
progression on the basis of IMWG SLiM-CRAB criteria, which may complicate
the evaluation of long-term outcomes such as overall survival
Primary endpoint1,2
PFS by independent review committee per IMWG SLiM-CRAB criteria*
Major secondary endpoints1,2
Overall response
Complete response rate
Disease progression as assessed with IMWG biochemical or SLiM-CRAB criteria
Time to first-line treatment for active MM
Death from any cause
*Evaluated in an analysis of the time from randomization to the initial
documentation of progression to active multiple myeloma or death from any cause, whichever
occurred first.
IMWG SLiM-CRAB diagnostic criteria for MM10:
Clonal BMPCs ≥10% or biopsy-proven bony or extramedullary plasmacytoma
AND
≥1 of the below multiple myeloma-defining events:
CRAB criteria
Calcium elevation: serum calcium >0.25 mmol/L (>1 mg/dL) higher than
the upper limit of normal of >2.75 mmol/L (>11 mg/dL)
Anemia: hemoglobin value >20 g/L below the limit of normal or a
hemoglobin value <100 g/L
Bone disease: ≥1 osteolytic lesions on skeletal radiography, CT, or
PET-CT
SLiM criteria
Clonal BMPCs: ≥60% BMPCs
Serum FLC: involved:uninvolved serum FLC ≥100
Focal lesions: ≥1 focal lesions on MRI studies
41%
of patients had 2 or more of the following criteria for high-risk smoldering
multiple myeloma: serum monoclonal protein level <2 g/dL, involved-to-uninvolved
serum-free light chain ratio <20, and bone marrow plasma cells <20%. DARZALEX
FASPRO® is only indicated for patients with high-risk smoldering multiple myeloma.
It is not indicated for other risk categories.1,2
Patient demographics2:
*Risk factors: serum M-protein ≥30 g/L, IgA SMM, immunoparesis with reduction
of 2 uninvolved immunoglobulin isotypes, serum involved:uninvolved FLC ratio ≥8 and
<100, or clonal BMPCs >50% to <60% with measurable disease. †Mayo 2018 risk criteria: serum M-protein >2 g/dL, involved:uninvolved FLC
ratio >20, and clonal BMPCs >20%. Patients with 0 factors = low risk, 1 factor =
intermediate risk, ≥2 factors = high risk. ‡Cytogenetic risk was assessed by fluorescence in situ hybridization.
The criteria defining high-risk SMM have evolved over the years and differ among
studies of interest for the treatment of this disease, highlighting a need for more
uniform criteria2
In AQUILA, the criteria for high-risk SMM were based on data available at the
time of trial development, before the establishment of Mayo 2018 risk criteria
With a median follow-up of 65.2 months (range, 0 to 76.6), progression to
active MM (IMWG SLiM-CRAB criteria) or death had occurred in 67 patients
(34.5%) in the DARZALEX FASPRO® group and in 99 patients (50.5%) in
the active monitoring group (HR, 0.49; 95% CI, 0.36-0.67;
P<0.001)2
Progression-free survival at 5 years was 63.1% in the DARZALEX FASPRO®
group compared with 40.8% in the active monitoring group2
ORR was 63.4% with DARZALEX FASPRO® treatment compared with 1.0% with
active monitoring
Response
DARZALEX
FASPRO® (n = 194)
Active
monitoring (n = 196)
ORR (sCR+CR+VGPR+PR), n (%)*ORR (sCR+CR+VGPR+PR), n (%)*
123 (63.4%)
2 (1.0%)
sCR
7 (3.6%)
0
CR
10 (5.2%)
0
VGPR
41 (21.1%)
1 (0.5%)
PR
65 (33.5%)
1 (0.5%)
*Based on intent-to-treat population per
investigator assessment.
This analysis is not included in the Prescribing Information for
DARZALEX FASPRO®.
Summary of progression events (intent-to-treat
population)2
No renal insufficiency was observed in either arm
*Disease progression was assessed by an independent review
committee in accordance with the IMWG SLiM-CRAB diagnostic criteria for
MM.
A patient could meet more than one criterion for disease progression. †Some patients met the CRAB criteria for renal insufficiency, but
the investigator attributed this to a cause other than disease progression to
MM.
This analysis is not included in the Prescribing Information for
DARZALEX FASPRO®.
Initiation of first-line MM treatment by clinical
cut-off
Response
DARZALEX
FASPRO® (n = 193)
Active
monitoring (n = 196)
Initiation of first-line treatment for MM
33.2%
53.6%
HR (95% CI)
0.46 (0.33-0.62)
5-year estimate
29.7%
55.9%
This analysis is not included in the Prescribing Information for
DARZALEX FASPRO®.
Overall survival in the intent-to-treat
population
OS
DARZALEX
FASPRO® (n = 194)
Active
monitoring (n = 196)
Deaths, n (%)
15 (7.7)
26 (13.3)
HR (95% CI)
0.52 (0.27-0.98)
5-year OS
93.0%
86.9%
This analysis is not included in the Prescribing Information for
DARZALEX FASPRO® and was conducted post hoc. Potential limitations on the
interpretation of post hoc analyses apply.
In AQUILA, 41% of patients were retrospectively classified as having
high-risk SMM based on IMWG 2020 (Mayo 2018 or 20/2/20) risk stratification as they met
at least 2 of the following criteria1,2:
Serum monoclonal protein level <2 g/dL
Involved-to-uninvolved serum-free light chain ratio >20
Bone marrow plasma cells >20%
The following data is from a post hoc analysis of these patients.
Baseline characteristics: patients with high-risk SMM per IMWG 2020 (Mayo
2018 or 20/2/20) criteria11*
DARZALEX FASPRO® n =
72
Active monitoring n = 86
Age, median (range)
64.0 (31-79)
65.0 (37-83)
Female, n (%)
36 (50.0)
45 (52.3)
Race, n (%)
White
60 (83.3)
67 (77.9)
Black or African American
2 (2.8)
6 (7.0)
Asian
7 (9.7)
8 (9.3)
American Indian or Alaska Native, Native Hawaiian or Pacific
Islander
0
2 (2.3)
Multiple/not reported
3 (4.2)
3 (3.5)
Baseline ECOG score, n (%)
0
61 (84.7)
66 (76.7)
1
11 (15.3)
20 (23.3)
ISS staging, N
70
85
I, n (%)
52 (74.3)
65 (76.5)
II, n (%)
17 (24.3)
18 (21.2)
III, n (%)
1 (1.4)
2 (2.4)
*IMWG 2020 (Mayo 2018 or 20/2/20) risk
was retrospectively assessed; criteria included serum M-protein ≥2 g/L,
involved:uninvolved FLC ratio ≥20, and clonal BMPCs ≥20%. Patients with ≥2 factors =
high risk.
Progression-free survival: patients with high-risk SMM per IMWG 2020
(Mayo 2018 or 20/2/20) criteria11*
Median follow-up of 65.2 months
Retrospective review of patients with high-risk SMM per IMWG 2020 (Mayo 2018 or
20/2/20) criteria showed median PFS was not reached for DARZALEX FASPRO® vs 22.1
months for active monitoring; HR, 0.36 (95% Cl, 0.23-0.58)12
The 60-month PFS rate was 60.4% for DARZALEX FASPRO® vs 23.6% for active
monitoring11
*IMWG 2020 (Mayo 2018 or 20/2/20) risk was retrospectively
assessed; criteria included serum M-protein ≥2 g/L, involved:uninvolved FLC ratio ≥20,
and clonal BMPCs ≥20%. Patients with ≥2 factors = high risk.
This analysis is not included in the Prescribing Information
for DARZALEX FASPRO® and was conducted post hoc. Potential limitations
on the interpretation of post hoc analyses apply.
*IMWG 2020 (Mayo 2018 or 20/2/20) risk was retrospectively
assessed; criteria included serum M-protein ≥2 g/L, involved:uninvolved
FLC ratio ≥20, and clonal BMPCs ≥20%. Patients with ≥2 factors = high
risk. †Hazard ratio and 95% CI was calculated using the Cox
proportional hazards model with treatment as the sole explanatory.
The most common adverse reactions (>20%) included1:
Upper respiratory tract infection
Musculoskeletal pain
Fatigue
Diarrhea
Rash
Sleep disorder
Sensory neuropathy
Injection site reactions
Serious adverse reactions occurred in 29% of patients who received DARZALEX FASPRO®. The
most frequent SAEs in >2% of patients who received DARZALEX FASPRO® were1:
Fatal adverse reactions occurred in 1% of patients who received DARZALEX FASPRO®,
including COVID-19 (0.5%) and pneumonia (0.5%)1
Permanent treatment discontinuation due to an adverse reaction occurred in 6% of
patients who received DARZALEX FASPRO®1
Adverse reactions which resulted in permanent discontinuation of DARZALEX FASPRO® in more
than 1 patient included fatigue, anxiety, and dyspnea1
Dosage interruptions of DARZALEX FASPRO® due to an adverse reaction occurred in 47%
of patients1
Adverse reactions which required dosage interruption in ≥5% of patients included
upper respiratory infection, pneumonia, and COVID-191
Adverse reaction
DARZALEX FASPRO® (n = 193)
Active monitoring (n = 196)
All grades (%)
Grade 3 or 4 (%)
All grades (%)
Grade 3 or 4 (%)
Infections
Upper respiratory tract infection*
66
1‡‡‡
27
0
Pneumonia†
16
7§§§
8
3‡‡‡
Rhinitis‡
10
0
2
0
Musculoskeletal and
connective tissue disorders
Musculoskeletal pain§
59
1‡‡‡
42
3‡‡‡
General disorders and
administration site conditions
Fatigue||
42
3‡‡‡
21
1‡‡‡
Injection site reactions¶
20
0
0
0
Infusion-related reactions#
17
1‡‡‡
0
0
Pyrexia
17
0
3
1‡‡‡
Edema**
15
1
5
1‡‡‡
Gastrointestinal disorders
Diarrhea
27
2‡‡‡
5
1‡‡‡
Nausea
19
0
5
0
Abdominal pain††
17
1‡‡‡
7
2‡‡‡
Skin and subcutaneous
tissue disorders
Rash‡‡
27
1‡‡‡
6
1‡‡‡
Psychiatric disorders
Sleep disorder§§
24
1‡‡‡
5
0
Nervous system disorders
Sensory neuropathy||||
20
0
8
0
Headache¶¶
18
1‡‡‡
8
0
Dizziness##
12
0
5
0
Respiratory, thoracic
and mediastinal disorders
Cough***
19
0
7
0
Dyspnea†††
18
1‡‡‡
6
1
*Upper respiratory tract infection includes acute
sinusitis, adenoviral upper respiratory infection, catarrh,
influenza, influenza like illness, laryngitis, metapneumovirus
infection, nasal congestion, nasopharyngitis, parainfluenzae virus
infection, pharyngitis, respiratory tract congestion, respiratory
tract infection, respiratory tract infection viral, sinus
congestion, sinusitis, throat irritation, tonsillitis, tracheitis,
upper respiratory tract congestion, upper respiratory tract
infection, upper respiratory tract infection bacterial, upper-airway
cough syndrome, and viral upper respiratory tract infection. †Pneumonia includes COVID-19 pneumonia, lower respiratory
tract infection, organizing pneumonia, pneumonia, pneumonia
bacterial, pneumonia pneumococcal, pneumonia streptococcal, and
pneumonia viral. ‡Rhinitis includes rhinitis, rhinitis atrophic,
rhinorrhea, rhinovirus infection, and viral rhinitis. §Musculoskeletal pain includes arthralgia, axillary pain,
back pain, breast pain, chest pain, facial spasm, fibromyalgia,
flank pain, groin pain, muscle fatigue, muscle rupture, muscle
spasms, muscle strain, muscle tightness, muscular weakness,
musculoskeletal chest pain, musculoskeletal pain, musculoskeletal
stiffness, myalgia, neck pain, non-cardiac chest pain, pain, pain in
extremity, pain in jaw, periarthritis, radicular pain, rotator cuff
syndrome, spinal pain, spinal stenosis, and tendon pain. ||Fatigue includes asthenia, fatigue, and malaise. ¶Injection site reaction includes injection site
discoloration, injection site erythema, injection site hemorrhage,
injection site induration, injection site edema, injection site
pain, injection site pruritus, injection site rash, injection site
swelling, injection site urticaria, injection site vesicles, and
injection site warmth. #Infusion-related reactions includes terms determined by
investigators to be related to infusion. **Edema includes brain edema, eye swelling, eyelid edema,
generalized edema, joint swelling, laryngeal edema, localized edema,
edema, edema peripheral, peripheral swelling, post procedural edema,
post procedural swelling, swelling face, and swelling of eyelid. ††Abdominal pain includes abdominal discomfort, abdominal
pain, abdominal pain lower, abdominal pain upper, abdominal
tenderness, epigastric discomfort, and gastrointestinal pain. ‡‡Rash includes acne, dermatitis, dermatitis allergic,
dermatitis bullous, dermatitis contact, drug eruption, drug
hypersensitivity, eczema, eczema asteatotic, eczema infected,
erysipelas, erythema, erythema multiforme, rash, rash erythematous,
rash maculo-papular, rash papular, rash pruritic, seborrheic
dermatitis, seborrheic keratosis, skin lesion, skin reaction, skin
ulcer, and urticaria. §§Sleep disorder includes insomnia, restless legs
syndrome, sleep apnea syndrome, sleep deficit, and sleep disorder. ||||Sensory neuropathy includes allodynia, anosmia,
burning sensation, carpal tunnel syndrome, cervical radiculopathy,
cervicobrachial syndrome, dysesthesia, hypoesthesia, hypoesthesia
oral, paresthesia, paresthesia oral, peripheral sensorimotor
neuropathy, peripheral sensory neuropathy, pharyngeal paresthesia,
polyneuropathy, and sensory disturbance. ¶¶Headache includes headache, migraine, and vascular
headache. ##Dizziness includes dizziness and dizziness postural. ***Cough includes cough and productive cough. †††Dyspnea includes dyspnea and dyspnea exertional. ‡‡‡Only Grade 3 adverse reactions occurred. §§§Fatal adverse reactions occurred for pneumonia: n=1
(1%) in the DARZALEX FASPRO® arm.
Clinically relevant adverse reactions in <10%
of patients who received DARZALEX FASPRO® included1:
Any AE occurred in 96.9% and 82.7% with DARZALEX FASPRO® and active monitoring,
respectively
Grade 3 or 4 AEs occurred in 40.4% and 30.1% with DARZALEX FASPRO® and
active monitoring, respectively
The most common Grade 3 or 4 AE was hypertension (5.7% vs 4.6%)
Serious AEs occurred in 29.0% and 19.4% with DARZALEX FASPRO® and active
monitoring, respectively
The most common serious AE was pneumonia (3.6% vs 0.5%)
Second primary cancer occurred in 9.3% and 10.2% with DARZALEX FASPRO® and
active monitoring, respectively
Contraindications1:
DARZALEX FASPRO® is
contraindicated
in patients with a history of severe hypersensitivity to daratumumab,
hyaluronidase, or any of the components of the formulation.
Hypersensitivity and other administration reactions
Both systemic administration-related reactions, including severe
or life-threatening reactions, and local injection-site reactions
can occur with DARZALEX FASPRO®
Fatal reactions have been reported with daratumumab-containing
products, including DARZALEX FASPRO®
Systemic reactions
In a pooled safety population of 1446 patients with multiple
myeloma (N=1253) or light chain (AL) amyloidosis (N=193) who
received DARZALEX FASPRO® as monotherapy or as part of a
combination therapy, 7% of patients experienced a systemic
administration-related reaction (Grade 2: 3%, Grade 3: 0.8%,
Grade 4: 0.1%)
In patients with high-risk smoldering multiple myeloma (N=193), systemic administration-related reactions occurred in 17% of patients in AQUILA (Grade 2: 7%, Grade 3: 1%)
In all patients, (N=1639), systemic administration-related
reactions occurred in 7% of patients with the first injection,
0.5% with the second injection, and cumulatively 1% with
subsequent injections
The median time to onset was 3.2 hours (range: 4 minutes to 3.5
days)
Of the 283 systemic administration-related reactions that
occurred in 135 patients, 240 (85%) occurred on the day of
DARZALEX FASPRO® administration
Delayed systemic administration-related reactions have occurred
in 1% of the patients
Severe reactions included hypoxia, dyspnea, hypertension,
tachycardia, and ocular adverse reactions, including choroidal
effusion, acute myopia, and acute angle closure glaucoma
Other signs and symptoms of systemic administration-related
reactions may include respiratory symptoms, such as bronchospasm,
nasal congestion, cough, throat irritation, allergic rhinitis, and
wheezing, as well as anaphylactic reaction, pyrexia, chest pain,
pruritus, chills, vomiting, nausea, hypotension, and blurred
vision
Pre-medicate patients with histamine-1 receptor antagonist,
acetaminophen, and corticosteroids
Monitor patients for systemic administration-related reactions,
especially following the first and second injections
For anaphylactic reaction or life-threatening (Grade 4)
administration-related reactions, immediately and permanently
discontinue DARZALEX FASPRO®
Consider administering corticosteroids and other medications
after the administration of DARZALEX FASPRO® depending on
dosing regimen and medical history to minimize the risk of delayed
(defined as occurring the day after administration) systemic
administration-related reactions
Ocular adverse reactions, including acute myopia and narrowing
of the anterior chamber angle due to ciliochoroidal effusions with
potential for increased intraocular pressure or glaucoma, have
occurred with daratumumab-containing products
If ocular symptoms occur, interrupt DARZALEX FASPRO® and
seek
immediate ophthalmologic evaluation prior to restarting
DARZALEX FASPRO®
Local reactions
In this pooled safety population of 1446 patients with multiple
myeloma (N=1253) or light chain (AL) amyloidosis (N=193),
injection-site reactions occurred in 8% of patients, including
Grade 2 reactions in 1.1%
The most frequent (>1%) injection-site reaction was
injection-site erythema and injection site rash
In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%
These local reactions occurred a median of 6 minutes (range: 0
minutes to 6.5 days) after starting administration of DARZALEX FASPRO®
Monitor for local reactions and consider symptomatic management
Infections
DARZALEX FASPRO® can cause serious, life-threatening, or
fatal infections
In patients who received DARZALEX FASPRO® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%
The most common type of serious infection reported was pneumonia
(8.5%)
Monitor patients for signs and symptoms of infection prior to and
during treatment with DARZALEX FASPRO® and treat
appropriately
Administer prophylactic antimicrobials according to guidelines
Neutropenia
DARZALEX FASPRO® may increase neutropenia induced by background therapy
Monitor complete blood cell counts periodically during treatment
according to manufacturer’s prescribing information for background
therapies
Monitor patients with neutropenia for signs of infection
Consider withholding DARZALEX FASPRO® until recovery of
neutrophils
In lower body weight patients receiving DARZALEX FASPRO®,
higher rates of Grade 3-4 neutropenia were observed
Thrombocytopenia
DARZALEX FASPRO® may increase thrombocytopenia induced by background
therapy
Monitor complete blood cell counts periodically during treatment
according to manufacturer’s prescribing information for background
therapies
Consider withholding DARZALEX FASPRO® until recovery of
platelets
Embryo-fetal toxicity
Based on the mechanism of action, DARZALEX FASPRO® can
cause fetal harm when administered to a pregnant woman
DARZALEX FASPRO® may cause depletion of fetal immune cells
and decreased bone density
Advise pregnant women of the potential risk to a fetus
Advise females with reproductive potential to use effective
contraception during treatment with DARZALEX FASPRO® and for
3 months after the last dose
The combination of DARZALEX FASPRO® with lenalidomide,
thalidomide, or pomalidomide is contraindicated in pregnant women
because lenalidomide, thalidomide, and pomalidomide may cause birth
defects and death of the unborn child
Refer to the lenalidomide, thalidomide, or pomalidomide
prescribing information on use during pregnancy
Interference with serological testing
DARZALEX FASPRO® binds to CD38 on RBCs and results in a positive
indirect antiglobulin test (indirect Coombs test)
Daratumumab-mediated positive indirect antiglobulin test may
persist for up to 6 months after the last DARZALEX FASPRO® administration
Daratumumab bound to RBCs masks detection of antibodies to minor
antigens in the patient’s serum
The determination of a patient’s ABO and Rh blood type are not
impacted
Notify blood transfusion centers of this interference with
serological testing and inform blood banks that a patient has
received DARZALEX FASPRO®
Type and screen patients prior to starting DARZALEX FASPRO®
Interference with determination of complete response
DARZALEX FASPRO® is a human IgG kappa monoclonal antibody that can be
detected on both the serum protein electrophoresis and
immunofixation assays used for the clinical monitoring of endogenous
M‑protein
This interference can impact the determination of complete
response and of disease progression in some DARZALEX FASPRO®-treated patients with IgG kappa myeloma protein
Adverse reactions
In multiple myeloma, the most common adverse reaction (≥20%) with
DARZALEX FASPRO® monotherapy is upper respiratory tract
infection
The most common adverse reactions with combination therapy (≥20%
for any combination) include fatigue, nausea, diarrhea, dyspnea,
sleep disorder, headache, rash, renal impairment, motor dysfunction,
pyrexia, cough, muscle spasms, back pain, vomiting, hypertension,
musculoskeletal pain, decreased appetite, urinary tract infection,
abdominal pain, upper respiratory tract infection, peripheral
neuropathy, peripheral sensory neuropathy, constipation, pneumonia,
edema, dizziness, bruising, and COVID-19
The most common adverse reactions (≥20%) in patients with
high-risk smoldering multiple myeloma who received DARZALEX FASPRO®
monotherapy are upper respiratory tract infection, musculoskeletal
pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy,
and injection site reactions
The most common hematology laboratory abnormalities (≥40%) with
DARZALEX FASPRO® are decreased leukocytes, decreased
lymphocytes, decreased neutrophils, decreased platelets, and
decreased hemoglobin
DARZALEX FASPRO® [Prescribing Information]. Horsham, PA: Janssen Biotech,
Inc.
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presentation presented at: 67th American Society of Hematology (ASH) Annual Meeting
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AE
Adverse event
ORR
Overall response rate
BMPC
Bone marrow plasma cells
OS
Overall survival
CI
Confidence interval
PD
Progressive disease
COVID-19
Coronavirus disease 2019
PET
Positron emission tomography
CR
Complete response
PFS
Progression-free survival
CRAB
Calcium elevation, renal insufficiency, anemia, bone disease
PR
Partial response
CT
Computed tomography
QW
Every week
ECOG PS
Eastern Cooperative Oncology Group performance status
