Minimal residual disease (MRD)-negativity rate of
10-5 more than doubled by 12 months with DARZALEX
FASPRO® in maintenance therapy compared to lenalidomide
alone, resulting in improvement in 30-month progression-free
survival
RIO DE
JANEIRO, Sept. 27, 2024 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) today announced data from
three studies highlighting clinical efficacy of
DARZALEX® (daratumumab) and DARZALEX
FASPRO® (daratumumab and
hyaluronidase-fihj) in maintenance regimens. Data
from the Phase 3 AURIGA study show DARZALEX
FASPRO® plus lenalidomide (D-R) maintenance
therapy following autologous stem cell transplant (ASCT)
significantly increases MRD-negative conversion rates at 12 months
compared to lenalidomide (R) maintenance alone in patients with
newly diagnosed multiple myeloma (NDMM). DARZALEX
FASPRO® plus lenalidomide maintenance therapy
also demonstrated a potential benefit in progression-free survival
(PFS) with no new safety concerns.1 Data were
featured in an oral presentation at the 2024 International Myeloma
Society (IMS) Annual Meeting (Abstract #OA – 45).
"The significant improvement in MRD-negative conversion rates
and the promising progression-free survival data suggest that this
maintenance regimen has the potential to improve longer-term
outcomes for patients with newly diagnosed multiple myeloma who are
transplant-eligible," said Dr. Ashraf
Badros, professor of medicine at the University of Maryland School of Medicine and
Director of the Multiple Myeloma Service at the University of Maryland Greenebaum Comprehensive
Cancer Center within University of
Maryland Medical Center in Maryland.* "Combining DARZALEX
FASPRO with lenalidomide in the maintenance setting offers
an advantage over lenalidomide alone for patients who are newly
diagnosed with multiple myeloma and anti-CD38 naïve."
In the AURIGA study, the D-R arm demonstrated a higher
MRD-negative (10-5) conversion rate by 12 months
compared to the R arm (50.5 percent vs 18.8 percent, odds ratio
[OR] 4.51, P<0.0001) and a superior >6-month sustained
MRD-negative rate (35.4 percent vs 13.9 percent, OR 3.40,
P=0.0005). Complete response (CR) or better rates were also
higher with D-R: 75.8 percent vs 61.4 percent (P=0.0255).
The increased MRD-negative conversion rate resulted in a PFS
favoring D-R (hazard ratio 0.53; 95% CI, 0.29-0.97) with an
estimated 30-month rate of 82.7 percent compared to 66.4 percent
for the R arm.1
"MRD-negativity is an important predictor of long-term
progression-free survival for patients with multiple myeloma, and
the FDA Oncologic Drugs Advisory Committee emphasized the value of
this when it unanimously decided that MRD could be used as a
primary endpoint in multiple myeloma clinical trials as a surrogate
for PFS," said Imran Khan, Vice
President, Medical Affairs, Hematology, Innovative Medicine,
Johnson & Johnson. "These results, along with the data being
presented from the Phase 3 CEPHEUS study, further underscore the
promising potential of DARZALEX FASPRO for newly diagnosed
patients, regardless of their transplant status."
Grade 3/4 treatment-related adverse events (TRAEs) occurred in
74 percent of patients treated with D-R and 67.3 percent of
patients treated with R; infections (18.8 percent and 13.3 percent)
and neutropenia (46.9 percent and 41.8 percent) were most
common.1
Additional data from Phase 3 PERSEUS study demonstrate
benefit of DARZALEX FASPRO®-based induction,
consolidation and maintenance regimens across cytogenetic risk
populations
Expanded analyses of the Phase 3 PERSEUS study show that
DARZALEX FASPRO® in combination with bortezomib,
lenalidomide and dexamethasone (D-VRd) in induction/consolidation
followed by a maintenance regimen of D-R induced deep and sustained
MRD-negativity compared to VRd regardless of disease stage based on
the second revised International Staging System (R2-ISS). In the
revised high-risk subgroup, treatment with D-VRd followed by D-R
maintenance results in higher rates of overall MRD-negativity at
10-6 with complete response or better compared to VRd
(63.1 percent vs 32.4 percent; P<0.0001) with sustained
MRD-negativity status for at least 12 months (42.3 percent vs 15.5
percent; P=0.0007).2
These data, including high-risk cytogenetic abnormalities
(HRCAs), including gain(1q21) and amp(1q21), will be presented in
an oral presentation at IMS (Abstract #OA – 48).
Phase 3 CASSIOPEIA MRD update shows deep and durable
responses with DARZALEX® in maintenance
therapy
Updated MRD data from the Phase 3 CASSIOPEIA study demonstrate
that including DARZALEX® in both
induction/consolidation and maintenance regimens resulted in deeper
and more durable MRD-negative responses at 10-5 level vs
bortezomib/thalidomide/dexamethasone (VTd) and observation: 77
percent vs 71 percent (P=0.0417). The benefit of
DARZALEX® monotherapy maintenance was demonstrated
in both patients who received VTd induction and consolidation, as
well as those who received DARZALEX® and VTd.
DARZALEX® maintenance reduced the risk of
progression or death by 24% in patients who received
DARZALEX® and VTd as induction and consolidation.
These results will be presented in an oral presentation at IMS
(Abstract #OA – 47).3
In the AURIGA, PERSEUS and CASSIOPEIA studies, the safety
profiles were consistent with the known safety profiles for
DARZALEX® and
DARZALEX FASPRO®.
About the AURIGA Study
The randomized study (NCT03901963) included 200 patients aged 18-79
years with newly diagnosed multiple myeloma who are minimal
residual disease (MRD)-positive after frontline autologous stem
cell transplant. Patients received 1800 milligram (mg) daratumumab
by subcutaneous (SC) injection in combination with lenalidomide
(orally) as maintenance therapy for a maximum of 36 cycles. Each
cycle is 28 days. Patients in the comparative arm will receive
lenalidomide (orally) alone as maintenance therapy for a maximum of
36 cycles. Each cycle is 28 days.4
About the CEPHEUS Study
CEPHEUS (NCT03652064) is an ongoing, multicenter, randomized,
open-label, Phase 3 study comparing the efficacy and safety of
D-VRd vs VRd in patients with newly diagnosed multiple myeloma who
are transplant-ineligible or for whom transplant is not intended as
initial therapy. Primary endpoint is MRD-negativity rate at
10-5 sensitivity threshold. Secondary endpoints include
PFS, MRD-negative rate at 1 year, durable MRD negativity, ORR, time
to and duration of response, PFS on next line of therapy, overall
survival and safety. The trial has enrolled 396 patients in 13
countries.
About the PERSEUS Study
The PERSEUS study
(NCT03710603) is being conducted in collaboration with the
European Myeloma Network as the sponsor. PERSEUS is an ongoing,
randomized, open-label, Phase 3 study comparing the efficacy and
safety of DARZALEX FASPRO® -VRd during induction
and consolidation versus VRd during induction and consolidation in
patients with NDMM eligible for ASCT. Following consolidation,
patients received an investigational treatment regimen for
maintenance that included DARZALEX FASPRO® in
combination with lenalidomide or lenalidomide alone. The trial was
not designed to isolate the effect of DARZALEX
FASPRO® in the maintenance phase of treatment.
The efficacy of DARZALEX FASPRO® in combination
with lenalidomide for maintenance has not been established. The
primary endpoint is PFS, and secondary endpoints include overall CR
or better rate, and overall MRD-negativity (in patients with CR or
better). The median age is 61.0 (range, 32-70) years for patients
in the D-VRd arm and 59.0 (range, 31-70) years for patients in the
VRd arm.5 The study is being conducted in 14
countries in Europe and
Australia.
About the CASSIOPEIA Study
The randomized, open-label,
multicenter, Phase 3 (NCT02541383) study is sponsored by the French
Intergroupe Francophone du Myelome in collaboration with the
Dutch-Belgian Cooperative Trial Group for Hematology Oncology and
Janssen Research & Development, LLC. This Phase 3 study
included 1,085 newly diagnosed patients with previously untreated,
symptomatic multiple myeloma who were eligible for high-dose
chemotherapy and stem cell transplant. Part one of the study
compared DARZALEX® (D) in combination with bortezomib,
thalidomide and dexamethasone (VTd) versus VTd induction and
consolidation therapy in patients with NDMM who were eligible for
autologous stem cell transplantation (ASCT) and demonstrated that
D-VTd yielded deeper responses and improved PFS. Part two of the
study compared D-maintenance therapy given every 8 weeks (at a
reduced frequency treatment schedule compared to the standard
long-term dosing frequency of every 4 weeks) versus observation.
The primary endpoint in this part of the study is the proportion of
patients who achieve a stringent complete response (sCR) 100 days
after transplant. In the second part of the study, which is
ongoing, patients who achieved a partial response or better in part
one will undergo a second randomization to receive maintenance
treatment with DARZALEX® 16 mg/kg every eight weeks for
up to two years or will be observed with no further treatment. The
primary endpoint in this part of the study is PFS.6
About Multiple Myeloma
Multiple myeloma is a blood cancer that affects a type of white
blood cell called plasma cells, which are found in the bone
marrow.7 In multiple myeloma, these malignant
plasma cells proliferate and replace normal cells in the bone
marrow.8 Multiple myeloma is the second most common
blood cancer worldwide and remains an incurable
disease.9 In 2024, it is estimated that more than 35,000
people will be diagnosed with multiple myeloma in the U.S. and
more than 12,000 will die from the disease. People with
multiple myeloma have a 5-year survival rate of 59.8
percent.10 While some people diagnosed with
multiple myeloma initially have no symptoms, most patients are
diagnosed due to symptoms that can include bone fracture or pain,
low red blood cell counts, tiredness, high calcium levels, kidney
problems or infections.11,12
About DARZALEX FASPRO® and
DARZALEX®
DARZALEX FASPRO® (daratumumab and
hyaluronidase-fihj) received U.S. FDA approval in May
2020 and is approved for nine indications in multiple myeloma, four
of which are for frontline treatment in newly diagnosed patients
who are transplant eligible or ineligible.14 It is
the only subcutaneous CD38-directed antibody approved to treat
patients with MM. DARZALEX FASPRO® is
co-formulated with recombinant human hyaluronidase PH20 (rHuPH20),
Halozyme's ENHANZE® drug delivery technology.
DARZALEX® (daratumumab) received U.S. FDA
approval in November 2015 and is approved in eight
indications, three of which are in the frontline setting, including
newly diagnosed patients who are transplant-eligible and
ineligible.6
DARZALEX® is the first CD38-directed antibody
approved to treat multiple
myeloma.6 DARZALEX®-based regimens have
been used in the treatment of more than 518,000 patients worldwide
and more than 68,000 patients in the U.S. alone.
In August 2012, Janssen Biotech, Inc. and Genmab A/S
entered a worldwide agreement, which granted Janssen an exclusive
license to develop, manufacture and commercialize daratumumab.
Since 2020, the National Comprehensive Cancer
Network® (NCCN®) has recommended
daratumumab-based combination regimens for the treatment of newly
diagnosed multiple myeloma and relapsed and refractory multiple
myeloma.† For newly diagnosed multiple myeloma in
non-transplant candidates, the NCCN® guidelines
recommend daratumumab in combination with lenalidomide and
dexamethasone as a Category 1 preferred regimen; daratumumab in
combination with bortezomib, melphalan, and prednisone as another
recommended Category 1 regimen; and daratumumab in combination with
bortezomib, cyclophosphamide, and prednisone as another recommended
Category 2A regimen. For newly diagnosed multiple myeloma in
transplant candidates, the NCCN® guidelines
recommend daratumumab in combination with bortezomib, lenalidomide
and dexamethasone as another recommended Category 2A regimen;
daratumumab in combination with bortezomib, thalidomide and
dexamethasone as a Category 2A regimen useful in certain
circumstances; daratumumab in combination with carfilzomib,
lenalidomide and dexamethasone as a Category 2A regimen useful in
certain circumstances; and daratumumab in combination with
cyclophosphamide, bortezomib and dexamethasone as a Category 2A
regimen useful in certain circumstances. For maintenance in
transplant candidates, the NCCN guidelines recommend daratumumab in
combination with lenalidomide as useful in certain circumstances.
In relapsed/refractory myeloma, four daratumumab regimens are
listed as Category 1 preferred regimens for early relapses (1-3
prior therapies): daratumumab in combination with lenalidomide and
dexamethasone; daratumumab in combination with bortezomib and
dexamethasone; daratumumab in combination with carfilzomib and
dexamethasone; and daratumumab in combination with pomalidomide and
dexamethasone [after one prior therapy including lenalidomide and a
proteasome inhibitor (PI)]. The NCCN® also
recommends daratumumab in combination with cyclophosphamide,
bortezomib and dexamethasone as another Category 2A regimen for
early relapses (1-3 prior therapies) and as monotherapy as a
Category 2A regimen useful in certain circumstances for early
relapse patients after at least three prior therapies, including a
PI and an immunomodulatory agent, or for patients who are double
refractory to a PI and an immunomodulatory agent.
For more information, visit www.DARZALEX.com.
DARZALEX® INDICATIONS AND IMPORTANT SAFETY
INFORMATION
INDICATIONS
DARZALEX® (daratumumab) is indicated for the
treatment of adult patients with multiple myeloma:
- In combination with bortezomib, melphalan, and prednisone in
newly diagnosed patients who are ineligible for autologous stem
cell transplant
- In combination with lenalidomide and dexamethasone in newly
diagnosed patients who are ineligible for autologous stem cell
transplant and in patients with relapsed or refractory multiple
myeloma who have received at least one prior therapy
- In combination with bortezomib, thalidomide, and dexamethasone
in newly diagnosed patients who are eligible for autologous stem
cell transplant
- In combination with pomalidomide and dexamethasone in patients
who have received at least one prior line of therapy including
lenalidomide and a proteasome inhibitor
- In combination with carfilzomib and dexamethasone in patients
with relapsed or refractory multiple myeloma who have received one
to three prior lines of therapy
- In combination with bortezomib and dexamethasone in patients
who have received at least one prior therapy
- As monotherapy in patients who have received at least three
prior lines of therapy including a proteasome inhibitor (PI) and an
immunomodulatory agent or who are double-refractory to a PI and an
immunomodulatory agent
CONTRAINDICATIONS
DARZALEX® is contraindicated in patients with a
history of severe hypersensitivity (eg, anaphylactic reactions) to
daratumumab or any of the components of the formulation.
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
DARZALEX® can cause severe and/or serious
infusion-related reactions including anaphylactic reactions. These
reactions can be lifethreatening, and fatal outcomes have been
reported. In clinical trials (monotherapy and combination: N=2066),
infusion-related reactions occurred in 37% of patients with the
Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and
cumulatively 6% with subsequent infusions. Less than 1% of patients
had a Grade 3/4 infusion-related reaction at Week 2 or subsequent
infusions. The median time to onset was 1.5 hours (range: 0 to 73
hours). Nearly all reactions occurred during infusion or within 4
hours of completing DARZALEX®. Severe reactions have
occurred, including bronchospasm, hypoxia, dyspnea, hypertension,
tachycardia, headache, laryngeal edema, pulmonary edema, and ocular
adverse reactions, including choroidal effusion, acute myopia, and
acute angle closure glaucoma. Signs and symptoms may include
respiratory symptoms, such as nasal congestion, cough, throat
irritation, as well as chills, vomiting, and nausea. Less common
signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest
discomfort, pruritus, hypotension and blurred vision.
When DARZALEX® dosing was interrupted in the
setting of ASCT (CASSIOPEIA) for a median of 3.75 months (range:
2.4 to 6.9 months), upon re-initiation of DARZALEX®, the
incidence of infusion-related reactions was 11% for the first
infusion following ASCT. Infusion-related reactions occurring at
re-initiation of DARZALEX® following ASCT were
consistent in terms of symptoms and severity (Grade 3 or 4: <1%)
with those reported in previous studies at Week 2 or subsequent
infusions. In EQUULEUS, patients receiving combination treatment
(n=97) were administered the first 16 mg/kg dose at Week 1 split
over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively. The
incidence of any grade infusion-related reactions was 42%, with 36%
of patients experiencing infusion-related reactions on Day 1 of
Week 1, 4% on Day 2 of Week 1, and 8% with subsequent
infusions.
Pre-medicate patients with antihistamines, antipyretics, and
corticosteroids. Frequently monitor patients during the entire
infusion. Interrupt DARZALEX® infusion for
reactions of any severity and institute medical management as
needed. Permanently discontinue DARZALEX® therapy if an
anaphylactic reaction or life-threatening (Grade 4) reaction occurs
and institute appropriate emergency care. For patients with Grade
1, 2, or 3 reactions, reduce the infusion rate when re-starting the
infusion.
To reduce the risk of delayed infusion-related reactions,
administer oral corticosteroids to all patients following
DARZALEX® infusions. Patients with a history of
chronic obstructive pulmonary disease may require additional
post-infusion medications to manage respiratory complications.
Consider prescribing short- and long-acting bronchodilators and
inhaled corticosteroids for patients with chronic obstructive
pulmonary disease.
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 DARZALEX® infusion. If ocular symptoms
occur, interrupt DARZALEX® infusion and seek immediate
ophthalmologic evaluation prior to restarting
DARZALEX®.
Interference With Serological Testing
Daratumumab binds to CD38 on red blood cells (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 daratumumab infusion.
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 is not impacted. Notify blood transfusion
centers of this interference with serological testing and inform
blood banks that a patient has received DARZALEX®. Type
and screen patients prior to starting
DARZALEX®.
Neutropenia and Thrombocytopenia
DARZALEX® may increase neutropenia and
thrombocytopenia 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® until recovery of neutrophils
or for recovery of platelets.
Interference With Determination of Complete Response
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal
antibody that can be detected on both the serum protein
electrophoresis (SPE) and immunofixation (IFE) 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 patients with IgG kappa myeloma
protein.
Embryo-Fetal Toxicity
Based on the mechanism of action, DARZALEX® can
cause fetal harm when administered to a pregnant woman.
DARZALEX® 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®
and for 3 months after the last dose.
The combination of DARZALEX® with lenalidomide,
pomalidomide, or thalidomide is contraindicated in pregnant women
because lenalidomide, pomalidomide, and thalidomide may cause birth
defects and death of the unborn child. Refer to the lenalidomide,
pomalidomide, or thalidomide prescribing information on use during
pregnancy.
ADVERSE REACTIONS
The most frequently reported adverse reactions (incidence ≥20%)
were: upper respiratory infection, neutropenia, infusionrelated
reactions, thrombocytopenia, diarrhea, constipation, anemia,
peripheral sensory neuropathy, fatigue, peripheral edema, nausea,
cough, pyrexia, dyspnea, and asthenia. The most common hematologic
laboratory abnormalities (≥40%) with DARZALEX® are:
neutropenia, lymphopenia, thrombocytopenia, leukopenia, and
anemia.
Please click here to see the full Prescribing
Information.
DARZALEX FASPRO® INDICATIONS AND IMPORTANT
SAFETY INFORMATION
INDICATIONS
DARZALEX FASPRO®
(daratumumab and hyaluronidase-fihj) is indicated for the treatment
of adult patients with multiple myeloma:
- In combination with bortezomib, lenalidomide, and
dexamethasone for induction and consolidation in newly diagnosed
patients who are eligible for autologous stem cell transplant
- In combination with bortezomib, melphalan, and prednisone in
newly diagnosed patients who are ineligible for autologous stem
cell transplant
- In combination with lenalidomide and dexamethasone in newly
diagnosed patients who are ineligible for autologous stem cell
transplant and in patients with relapsed or refractory multiple
myeloma who have received at least one prior therapy
- In combination with bortezomib, thalidomide, and dexamethasone
in newly diagnosed patients who are eligible for autologous stem
cell transplant
- In combination with pomalidomide and dexamethasone in patients
who have received at least one prior line of therapy including
lenalidomide and a proteasome inhibitor (PI)
- In combination with carfilzomib and dexamethasone in patients
with relapsed or refractory multiple myeloma who have received one
to three prior lines of therapy
- In combination with bortezomib and dexamethasone in patients
who have received at least one prior therapy
- As monotherapy in patients who have received at least three
prior lines of therapy including a PI and an immunomodulatory agent
or who are double refractory to a PI and an immunomodulatory
agent
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DARZALEX FASPRO® is contraindicated in patients
with a history of severe hypersensitivity to daratumumab,
hyaluronidase, or any of the components of the
formulation.
WARNINGS AND PRECAUTIONS
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 1249 patients with multiple
myeloma (N=1056) or light chain (AL) amyloidosis (N=193) who
received DARZALEX FASPRO® as monotherapy or in
combination, 7% of patients experienced a systemic
administration-related reaction (Grade 2: 3.2%, Grade 3: 0.7%,
Grade 4: 0.1%). Systemic administration-related reactions occurred
in 7% of patients with the first injection, 0.2% with the second
injection, and cumulatively 1% with subsequent injections. The
median time to onset was 2.9 hours (range: 5 minutes to 3.5 days).
Of the 165 systemic administration-related reactions that occurred
in 93 patients, 144 (87%) 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, injection-site reactions occurred
in 7% of patients, including Grade 2 reactions in 0.8%. The most
frequent (>1%) injection-site reaction was injection-site
erythema. These local reactions occurred a median of 5 minutes
(range: 0 minutes to 6.5 days) after starting administration of
DARZALEX FASPRO®. Monitor for local reactions and
consider symptomatic management.
Neutropenia
Daratumumab 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
Daratumumab 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
Daratumumab binds to CD38 on red blood cells (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 daratumumab
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
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal
antibody that can be detected on both the serum protein
electrophoresis (SPE) and immunofixation (IFE) 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, insomnia, headache, pyrexia, cough,
muscle spasms, back pain, vomiting, hypertension, upper respiratory
tract infection, peripheral sensory neuropathy, constipation,
pneumonia, and peripheral edema.
The most common hematology laboratory abnormalities (≥40%) with
DARZALEX FASPRO® are decreased leukocytes,
decreased lymphocytes, decreased neutrophils, decreased platelets,
and decreased hemoglobin.
Please click here to see the full Prescribing Information for
DARZALEX FASPRO®.
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.com/ or at
www.janssen.com/johnson-johnson-innovative-medicine. Follow us at
@JanssenUS and @JNJInnovMed. Janssen Research &
Development, LLC and Janssen Biotech, Inc., Janssen Global
Services, LLC and Janssen Scientific Affairs, LLC are Johnson &
Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits and
treatment impact of DARZALEX® and DARZALEX
FASPRO®. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Janssen Research & Development, LLC, Janssen
Biotech, Inc. Janssen Global Services, LLC, Janssen
Scientific Affairs, LLC and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to: challenges
and uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 31, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson's subsequent Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. Copies of
these filings are available online at www.sec.gov, www.jnj.com or
on request from Johnson & Johnson. None of Janssen Research
& Development, LLC, Janssen Biotech, Inc., Janssen
Global Services, LLC, Janssen Scientific Affairs, LLC nor
Johnson & Johnson undertake to update any forward-looking
statement as a result of new information or future events or
developments.
Source: Johnson & Johnson
* Dr. Ashraf
Badros, University of Maryland
Medical Center in Maryland has
provided consulting, advisory, and speaking services to Johnson
& Johnson; he has not been paid for any media work.
† The NCCN Content does not constitute medical advice and should
not be used in place of seeking professional medical advice,
diagnosis or treatment by licensed practitioners. NCCN makes no
warranties of any kind whatsoever regarding their content, use or
application and disclaims any responsibility for their application
or use in any way. See the NCCN Guidelines for detailed
recommendations, including other treatment options.
1 Badros,
A., et al. Subcutaneous Daratumumab Plus Lenalidomide Versus
Lenalidomide Alone as Maintenance Therapy in Newly Diagnosed
Multiple Myeloma After Transplant: Primary Results from the Phase 3
AURIGA Study. IMS 2024. September 27, 2024.
2 Dimopoulos, M., et al. Daratumumab
(DARA)/Bortezomib/Lenalidomide/ Dexamethasone (D-VRd) With D-R
Maintenance (Maint) in Transplant-eligible (TE) Newly Diagnosed
Myeloma (NDMM): PERSEUS Cytogenetic Risk Analysis. IMS 2024.
September 27, 2024.
3 Corre, J., et al. Daratumumab (DARA) +
Bortezomib/Thalidomide/ Dexamethasone (D-VTd) and DARA Maintenance
in Transplanteligible Newly Diagnosed Multiple Myeloma (NDMM):
CASSIOPEIA Minimal Residual Disease (MRD) Update. IMS 2024.
September 27, 2024.
4 ClinicalTrials.gov Identifier NCT03901963.
Accessed August 2024.
https://clinicaltrials.gov/study/NCT03901963
5 Pieter Sonneveld, Dimopoulos MA, Boccadoro M, et
al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for
Multiple Myeloma. The New England Journal of
Medicine. Accessed August 2024.
https://www.nejm.org/doi/full/10.1056/NEJMoa2312054
6 ClinicalTrials.gov Identifier NCT02541383.
Accessed August 2024.
https://clinicaltrials.gov/study/NCT02541383
7 Rajkumar SV. Multiple Myeloma: 2020 Update on
Diagnosis, Risk-Stratification and Management. Am J
Hematol. 2020;95(5):548-5672020;95(5):548-567.
http://www.ncbi.nlm.nih.gov/pubmed/32212178
8 National Cancer Institute. Plasma Cell Neoplasms.
Accessed August 2024. Available at:
https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq
9 Multiple Myeloma. City of Hope, 2022. Multiple
Myeloma: Causes, Symptoms & Treatments. Accessed August 2024.
Available at:
https://www.cancercenter.com/cancer-types/multiple-myeloma
10 American Cancer Society. Myeloma Cancer
Statistics. Accessed August 2024. Available at:
https://cancerstatisticscenter.cancer.org/types/myeloma
11 American Cancer Society. What is Multiple
Myeloma? Accessed August 2024. Available at:
https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
12 American Cancer Society. Multiple Myeloma Early
Detection, Diagnosis, and Staging. Accessed August 2024. Available
at:
https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html
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