If approved, DARZALEX
FASPRO® will become the first treatment
option for patients with smoldering multiple myeloma at high-risk
of developing multiple myeloma, offering a novel approach to treat
before the onset of active disease and the occurrence of end organ
damage
RARITAN,
N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson
& Johnson (NYSE:JNJ) today announced the submission of
regulatory applications to the U.S. Food and Drug Administration
(FDA) and European Medicines Agency (EMA) seeking approval of a new
indication for DARZALEX FASPRO® (daratumumab and
hyaluronidase-fihj) in the U.S. and DARZALEX®
subcutaneous (SC) formulation in the European Union
(EU). The applications are supported by data from the ongoing Phase
3 AQUILA study (NCT03301220) of DARZALEX
FASPRO® as monotherapy for the treatment of
adult patients with high-risk smoldering multiple
myeloma.1
Smoldering multiple myeloma is an early precursor of active
multiple myeloma, where abnormal cells can be detected in the bone
marrow, but patients are typically asymptomatic.2
Fifteen percent of all cases of newly diagnosed multiple myeloma
are classified as smoldering multiple myeloma, and half of those
diagnosed with high-risk disease will progress to active multiple
myeloma within two years.3 Currently, smoldering
multiple myeloma is not generally treated until active multiple
myeloma develops. Instead, the standard approach is observation to
track the disease for signs of biochemical progression and/or end
organ damage, when treatment tends to be initiated.2
Recent evidence suggests that those at high-risk for progression to
active multiple myeloma could benefit from earlier therapeutic
intervention.4
"There remains an unmet need for early interventions and
treatments that are both effective and well tolerated in people
living with smoldering multiple myeloma at high-risk of progressing
to active multiple myeloma," said Yusri
Elsayed, M.D., M.H.Sc., Ph.D. Global Therapeutic Area Head,
Oncology, Innovative Medicine, Johnson & Johnson. "DARZALEX has
changed the standard of care in multiple myeloma, and with these
submissions to the FDA and EMA, this therapy could become the first
approved treatment for patients with high-risk smoldering multiple
myeloma, potentially shifting the treatment paradigm."
The first data from the AQUILA study, evaluating the safety and
efficacy of DARZALEX FASPRO® compared to active
monitoring in participants with high-risk smoldering multiple
myeloma, will be presented at the 2024 American Society of
Hematology (ASH) Annual Meeting, taking place in San Diego from December
7-10.4
About the AQUILA Study
AQUILA (NCT03301220) is a
randomized, multicenter Phase 3 study investigating DARZALEX
FASPRO® versus active monitoring in patients
(n=390) with high-risk smoldering multiple myeloma.1 The
primary endpoint is progression free survival and secondary
endpoints include time to progression, overall response rate and
overall survival.1 Patients in the study were diagnosed
with smoldering multiple myeloma in the last five years and were
excluded if they had prior exposure to approved or investigational
treatments for smoldering multiple myeloma or multiple
myeloma.1
About Smoldering Multiple Myeloma
Smoldering
multiple myeloma is an asymptomatic precursor state to
multiple myeloma. Patients with smoldering multiple myeloma have
higher levels of abnormal plasma cells in the bone marrow and an
elevated monoclonal protein (M-protein) level in the blood, but
they do not yet exhibit the symptoms commonly associated with
active multiple myeloma, particularly end-organ damage. Fifteen
percent of all cases of newly diagnosed multiple myeloma are
classified as smoldering multiple myeloma, and half of those
diagnosed with high-risk disease will progress to active multiple
myeloma within two years.3
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.5 In multiple
myeloma, these malignant plasma cells proliferate and replace
normal cells in the bone marrow.6 Multiple myeloma
is the second most common blood cancer worldwide and remains an
incurable disease.7 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.8 People with multiple myeloma have a
5-year survival rate of 59.8 percent.8 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.9,10
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.11 It is the only subcutaneous
CD38-directed antibody approved to treat patients with multiple
myeloma. 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.12
DARZALEX® is the first CD38-directed antibody
approved to treat multiple myeloma.12
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.
For more information, visit www.DARZALEX.com.
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®.
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 for DARZALEX®.
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
www.jnj.com or at www.innovativemedicine.jnj.com. Follow us
at @JanssenUS and @JNJInnovMed. Janssen Research &
Development, LLC and Janssen Biotech, Inc. 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 FASPRO® (daratumumab and
hyaluronidase-fihj). 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. 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., nor Johnson &
Johnson undertake to update any forward-looking statement as a
result of new information or future events or developments.
1 ClinicalTrials.Gov. A Study of Subcutaneous
Daratumumab Versus Active Monitoring in Participants With High-Risk
Smoldering Multiple Myeloma. Accessed October 2024. Available at: Study Details | A
Study of Subcutaneous Daratumumab Versus Active Monitoring in
Participants With High-Risk Smoldering Multiple Myeloma |
ClinicalTrials.gov
2 Myeloma UK. Smouldering myeloma. Accessed October 2024. Available at:
https://www.myeloma.org.uk/understanding-myeloma/related-conditions/smouldering-myeloma/#:~:text=In%20smouldering%20myeloma%20abnormal%20cells,generally%20do%20not%20require%20treatment.
3 Rajkumar SV, Kumar S, Lonial S, Mateos MV. Smoldering
multiple myeloma current treatment algorithms. Blood Cancer J. 2022
Sep 5;12(9):129.
4 M.A. Dimopoulos, et al. Phase 3 Randomized Study of
Daratumumab Monotherapy Versus Active Monitoring in Patients With
High-risk Smoldering Multiple Myeloma: Primary Results of the
AQUILA Study. Presented at the December
2024 ASH Annual Meeting & Exposition. Abstract
JJD-78127.
5 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
6 National Cancer Institute. Plasma Cell Neoplasms.
Accessed October 2024. Available at:
https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq
7 Multiple Myeloma. City of Hope, 2022. Multiple
Myeloma: Causes, Symptoms & Treatments. Accessed October 2024. Available at:
https://www.cancercenter.com/cancer-types/multiple-myeloma
8 American Cancer Society. Myeloma Cancer Statistics.
Accessed October 2024. Available
at: https://cancerstatisticscenter.cancer.org/types/myeloma
9 American Cancer Society. What is Multiple Myeloma?
Accessed October 2024. Available
at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
10 American Cancer Society. Multiple Myeloma Early
Detection, Diagnosis, and Staging. Accessed October 2024. Available at:
https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html
11 DARZALEX FASPRO® U.S. Prescribing
Information
12 DARZALEX® U.S. Prescribing Information
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