Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma
Johnson & Johnson (NYSE:JNJ) has submitted regulatory applications to the FDA and EMA seeking approval for DARZALEX FASPRO® as the first treatment for high-risk smoldering multiple myeloma. The applications are supported by the Phase 3 AQUILA study data. Smoldering multiple myeloma, an early precursor to active multiple myeloma, affects 15% of newly diagnosed multiple myeloma cases, with half of high-risk patients progressing to active disease within two years. Currently, the standard approach is observation until active disease develops. The first data from the AQUILA study will be presented at the 2024 ASH Annual Meeting in December.
Johnson & Johnson (NYSE:JNJ) ha presentato domande regulatory alla FDA e all'EMA per ottenere l'approvazione di DARZALEX FASPRO® come primo trattamento per il mieloma multiplo smoldering ad alto rischio. Le domande sono supportate dai dati dello studio di Fase 3 AQUILA. Il mieloma multiplo smoldering, precursore iniziale del mieloma multiplo attivo, colpisce il 15% dei casi di mieloma multiplo neodiagnosticati, con la metà dei pazienti ad alto rischio che progredisce verso una malattia attiva entro due anni. Attualmente, l'approccio standard prevede l'osservazione fino allo sviluppo della malattia attiva. I primi dati dello studio AQUILA saranno presentati alla Riunione Annuale ASH 2024 a dicembre.
Johnson & Johnson (NYSE:JNJ) ha presentado solicitudes regulatorias a la FDA y a la EMA para buscar la aprobación de DARZALEX FASPRO® como el primer tratamiento para el mieloma múltiple smoldering de alto riesgo. Las solicitudes están respaldadas por los datos del estudio de Fase 3 AQUILA. El mieloma múltiple smoldering, un precursor temprano del mieloma múltiple activo, afecta al 15% de los casos recién diagnosticados de mieloma múltiple, con la mitad de los pacientes de alto riesgo progresando a enfermedad activa dentro de dos años. Actualmente, el enfoque estándar es la observación hasta que se desarrolle la enfermedad activa. Los primeros datos del estudio AQUILA se presentarán en la Reunión Anual de ASH 2024 en diciembre.
존슨앤존슨 (NYSE:JNJ)은 고위험 소엽성 다발성 골수종에 대한 첫 번째 치료제로 DARZALEX FASPRO®의 승인을 얻기 위해 FDA와 EMA에 규제 신청서를 제출했습니다. 이 신청서는 3상 AQUILA 연구 데이터에 기반하고 있습니다. 소엽성 다발성 골수종은 활성 다발성 골수종의 초기 전조로, 새로 진단된 다발성 골수종 환자의 15%에게 영향을 미치며, 고위험 환자의 절반은 2년 이내에 활성 질병으로 진행됩니다. 현재 표준 접근법은 활성 질병이 발생할 때까지 관찰하는 것입니다. AQUILA 연구의 첫 번째 데이터는 2024년 12월 ASH 연례 회의에서 발표될 예정입니다.
Johnson & Johnson (NYSE:JNJ) a soumis des demandes réglementaires à la FDA et à l'EMA pour obtenir l'approbation de DARZALEX FASPRO® en tant que premier traitement pour le myélome multiple smoldering à haut risque. Les demandes sont étayées par les données de l'étude de phase 3 AQUILA. Le myélome multiple smoldering, un précurseur précoce du myélome multiple actif, affecte 15 % des cas nouvellement diagnostiqués de myélome multiple, la moitié des patients à haut risque progressant vers une maladie active dans les deux ans. Actuellement, l'approche standard consiste à observer jusqu'au développement de la maladie active. Les premières données de l'étude AQUILA seront présentées lors de la réunion annuelle de l'ASH en décembre 2024.
Johnson & Johnson (NYSE:JNJ) hat regulatorische Anträge bei der FDA und der EMA eingereicht, um die Genehmigung für DARZALEX FASPRO® als erste Behandlung von hochrisiko-schlummerndem multiples Myelom zu beantragen. Die Anträge basieren auf den Daten der Phase-3-Studie AQUILA. Das schlummernde multiple Myelom, ein frühes Vorstadium des aktiven multiplen Myeloms, betrifft 15% der neu diagnostizierten Fälle von multiplem Myelom, wobei die Hälfte der Hochrisikopatienten innerhalb von zwei Jahren zu einer aktiven Erkrankung übergeht. Derzeit besteht der Standardansatz darin, zu beobachten, bis sich eine aktive Erkrankung entwickelt. Die ersten Daten der AQUILA-Studie werden auf dem ASH-Jahrestreffen 2024 im Dezember präsentiert.
- Potential first-mover advantage in treating high-risk smoldering multiple myeloma
- Expansion of DARZALEX FASPRO® into a new therapeutic indication
- Large addressable market with 15% of multiple myeloma cases being smoldering type
- None.
Insights
The regulatory submission for DARZALEX FASPRO® represents a significant potential breakthrough in multiple myeloma treatment. The focus on treating high-risk smoldering multiple myeloma (SMM) before it progresses to active disease marks a paradigm shift in treatment strategy. Currently, 50% of high-risk SMM patients progress to active multiple myeloma within two years, highlighting the critical need for early intervention.
The AQUILA Phase 3 study's results, pending presentation at ASH, could establish DARZALEX FASPRO® as the first approved treatment for high-risk SMM. This subcutaneous formulation offers improved administration convenience over traditional intravenous delivery. If approved, this would transform the current "watch and wait" approach to an active treatment strategy, potentially preventing or delaying progression to active disease.
This regulatory submission could significantly expand DARZALEX's market opportunity. With 15% of newly diagnosed multiple myeloma cases classified as SMM, approval in this indication would allow J&J to capture patients earlier in the disease progression, potentially extending the duration of therapy. The subcutaneous formulation's patent protection and convenience advantages also strengthen J&J's competitive position in the multiple myeloma market.
Success in this indication could drive meaningful revenue growth for DARZALEX, already a multi-billion dollar franchise. Early intervention in high-risk SMM represents an untapped market segment with substantial commercial potential, particularly given the lack of approved alternatives.
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
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
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
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
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
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,
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
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 (≥
The most common hematology laboratory abnormalities (≥
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
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
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 ≥
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
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®
12 DARZALEX®
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FAQ
What new indication is Johnson & Johnson (JNJ) seeking approval for DARZALEX FASPRO®?
When will Johnson & Johnson (JNJ) present the AQUILA study data for DARZALEX FASPRO®?