DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible
Johnson & Johnson (NYSE:JNJ) announced FDA approval for DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The approval is based on the Phase 3 PERSEUS study, which showed:
1. 60% reduction in risk of disease progression or death with D-VRd compared to VRd
2. Improved minimal residual disease negativity rates: 57.5% vs 32.5%
3. Deeper responses at the end of consolidation
This quadruplet therapy offers a new frontline treatment option that may significantly improve outcomes for patients. The safety profile was consistent with known profiles for DARZALEX FASPRO® and VRd.
Johnson & Johnson (NYSE:JNJ) ha annunciato l'approvazione da parte della FDA per DARZALEX FASPRO® in combinazione con bortezomib, lenalidomide e desametasone (D-VRd) per pazienti con mieloma multiplo recentemente diagnosticato idonei per trapianto autologo di cellule staminali. L'approvazione si basa sullo studio di Fase 3 PERSEUS, che ha mostrato:
1. Riduzione del rischio di progressione della malattia o morte del 60% con D-VRd rispetto a VRd
2. Aumento delle percentuali di negatività della malattia residua minima: 57,5% contro 32,5%
3. Risposte più profonde alla fine della consolidazione
Questa terapia quadrupla offre una nuova opzione di trattamento di prima linea che può migliorare significativamente i risultati per i pazienti. Il profilo di sicurezza era coerente con i profili conosciuti per DARZALEX FASPRO® e VRd.
Johnson & Johnson (NYSE:JNJ) anunció la aprobación de la FDA para DARZALEX FASPRO® en combinación con bortezomib, lenalidomida y dexametasona (D-VRd) para pacientes con mieloma múltiple recién diagnosticado que son elegibles para trasplante autólogo de células madre. La aprobación se basa en el estudio de Fase 3 PERSEUS, que mostró:
1. Reducción del 60% en el riesgo de progresión de la enfermedad o muerte con D-VRd en comparación con VRd
2. Mejora en las tasas de negatividad de enfermedad residual mínima: 57,5% frente a 32,5%
3. Respuestas más profundas al final de la consolidación
Esta terapia cuadruplicada ofrece una nueva opción de tratamiento de primera línea que puede mejorar significativamente los resultados para los pacientes. El perfil de seguridad fue consistente con los perfiles conocidos para DARZALEX FASPRO® y VRd.
존슨앤드존슨 (NYSE:JNJ)은 자가 조혈모세포 이식을 받을 자격이 있는 새롭게 진단된 다발성 골수종 환자를 위해 보르테조밉, 레날리도마이드, 덱사메타손(D-VRd)과 함께 DARZALEX FASPRO®의 FDA 승인을 발표했습니다. 이 승인은 3상 PERSEUS 연구를 기반으로 하며, 이 연구는 다음과 같은 결과를 보여주었습니다:
1. D-VRd는 VRd에 비해 질병 진행 또는 사망 위험을 60% 감소시킵니다.
2. 최소 잔여 질병 음성 비율이 개선되었습니다: 57.5% 대 32.5%
3. 통합 종료 시 더 깊은 반응을 보였습니다.
이 4제요법은 환자들에게 결과를 상당히 개선할 수 있는 새로운 1차 치료 옵션을 제공합니다. 안전성 프로파일은 DARZALEX FASPRO® 및 VRd의 알려진 프로파일과 일치했습니다.
Johnson & Johnson (NYSE:JNJ) a annoncé l'approbation de la FDA pour DARZALEX FASPRO® en combinaison avec le bortezomib, la lénaïdomide et la dexaméthasone (D-VRd) pour les patients récemment diagnostiqués avec un myélome multiple éligibles pour une greffe autologue de cellules souches. L'approbation est basée sur l'étude de phase 3 PERSEUS, qui a montré :
1. Réduction de 60 % du risque de progression de la maladie ou de décès avec D-VRd par rapport à VRd
2. Amélioration des taux de négativité de la maladie résiduelle minimale : 57,5 % contre 32,5 %
3. Réponses plus profondes à la fin de la consolidation
Cette thérapie quadruple offre une nouvelle option de traitement en première ligne qui pourrait améliorer significativement les résultats pour les patients. Le profil de sécurité était cohérent avec les profils connus pour DARZALEX FASPRO® et VRd.
Johnson & Johnson (NYSE:JNJ) hat die FDA-Zulassung für DARZALEX FASPRO® in Kombination mit Bortezomib, Lenalidomid und Dexamethason (D-VRd) für neu diagnostizierte Patienten mit multiplem Myelom, die für eine autologe Stammzelltransplantation in Frage kommen, bekannt gegeben. Die Genehmigung basiert auf der Phase-3-Studie PERSEUS, die folgendes zeigte:
1. 60%ige Reduktion des Risikos einer Krankheitsprogression oder des Todes mit D-VRd im Vergleich zu VRd
2. Verbesserte Raten der negativen minimalen Restkrankheit: 57,5% gegenüber 32,5%
3. Tiefere Ansprechraten am Ende der Konsolidierung
Diese Quadruplet-Therapie bietet eine neue Erstlinienbehandlungsoption, die die Ergebnisse für Patienten erheblich verbessern könnte. Das Sicherheitsprofil war konsistent mit den bekannten Profilen von DARZALEX FASPRO® und VRd.
- FDA approval for DARZALEX FASPRO® in combination therapy (D-VRd) for newly diagnosed multiple myeloma patients
- 60% reduction in risk of disease progression or death compared to standard treatment
- Improved minimal residual disease negativity rates: 57.5% vs 32.5%
- Deeper responses at the end of consolidation therapy
- Potential to significantly delay disease progression in frontline treatment
- None.
The FDA approval of DARZALEX FASPRO® in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients eligible for stem cell transplant is a significant development in the field of oncology. The Phase 3 PERSEUS study results are particularly impressive, showing a
Key points to consider:
- The quadruplet therapy's ability to induce deeper responses, with
57.5% of patients achieving minimal residual disease (MRD) negativity compared to32.5% with VRd, is a strong indicator of improved long-term outcomes. - The higher MRD-negativity rates in patients with complete response or better (
76.6% vs58.5% ) suggest that this regimen could potentially lead to longer remissions and improved survival rates. - The safety profile of D-VRd appears consistent with known profiles of DARZALEX FASPRO® and VRd, which is reassuring for its clinical application.
This approval solidifies DARZALEX FASPRO®'s position as a foundational frontline therapy in multiple myeloma, potentially changing the standard of care for newly diagnosed, transplant-eligible patients. The subcutaneous administration of DARZALEX FASPRO® also offers practical advantages over intravenous formulations, potentially improving patient quality of life during treatment.
The FDA approval of DARZALEX FASPRO®-based quadruplet therapy for newly diagnosed multiple myeloma patients is a positive development for Johnson & Johnson (NYSE:JNJ). This approval expands the drug's market potential and reinforces its position in the competitive oncology space.
Financial implications to consider:
- Expanded market: This approval allows JNJ to target the newly diagnosed, transplant-eligible multiple myeloma patient population, potentially increasing the drug's revenue stream.
- First-mover advantage: As the first-ever quadruplet therapy study with subcutaneous DARZALEX FASPRO®, JNJ gains a competitive edge in the multiple myeloma market.
- Long-term revenue potential: The significant improvement in progression-free survival could lead to extended treatment duration, potentially increasing the lifetime value per patient.
- Market share growth: The impressive efficacy data may drive increased adoption among oncologists, potentially growing DARZALEX FASPRO®'s market share in the multiple myeloma space.
While specific revenue projections aren't provided, this approval strengthens JNJ's oncology portfolio and could contribute positively to the company's pharmaceutical segment performance. Investors should monitor future earnings reports for indications of DARZALEX FASPRO®'s sales growth following this expanded indication.
Findings from first-ever quadruplet therapy study with subcutaneous DARZALEX FASPRO® showed 60 percent reduction in risk of disease progression or death
New regimen solidifies DARZALEX FASPRO® as a foundational frontline therapy in multiple myeloma with potential to significantly delay disease progression
This approval is supported by data from the Phase 3 PERSEUS study evaluating DARZALEX FASPRO® in a regimen that included D-VRd induction and consolidation therapy compared to bortezomib, lenalidomide and dexamethasone (VRd) during induction and consolidation in patients with NDMM eligible for ASCT.1 Following consolidation, patients received an investigational treatment regimen for maintenance that included DARZALEX FASPRO® in combination with lenalidomide or lenalidomide alone.1
"Multiple myeloma has a highly varied clinical course among patients and in each individual patient, and there is a continued need for innovation and therapies that employ different targets and combinations to provide patients with treatment options at diagnosis and throughout the course of their disease," said Amrita Y. Krishnan, M.D., Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope.* "The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding D-VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation."
Findings from the PERSEUS study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with D-VRd reducing the risk of disease progression or death by 60 percent compared to VRd (HR [
"This latest indication for DARZALEX FASPRO-based quadruplet therapy demonstrated a clinically significant reduction in disease progression or death during first-line treatment when patients are likely to experience their deepest responses," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. "Today's approval embodies our commitment to setting new standards of care for patients newly diagnosed with multiple myeloma who are transplant eligible."
The overall safety profile of D-VRd was consistent with the known safety profiles for DARZALEX FASPRO® and VRd.1 The most common adverse reactions (≥
About the PERSEUS Study
The PERSEUS study 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 D-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.2 The study is being conducted in 14 countries in
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.3 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.4 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.5 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the
About DARZALEX FASPRO®
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.1 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.
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 https://www.darzalexhcp.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 read 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. are both 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 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.
*Dr. Amrita Y. Krishnan has provided consulting, advisory, and speaking services to Johnson & Johnson; she has not been paid for any media work.
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1 DARZALEX FASPRO® |
2 Pieter Sonneveld, Dimopoulos MA, Boccadoro M, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. The New England Journal of Medicine. Accessed July 2024. https://www.nejm.org/doi/full/10.1056/NEJMoa2312054 |
3 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 |
4 National Cancer Institute. Plasma Cell Neoplasms. Accessed July 2024. Available at: https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq |
5 Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed July 2024. Available at: https://www.cancercenter.com/cancer-types/multiple-myeloma |
6 American Cancer Society. Myeloma Cancer Statistics. Accessed July 2024. Available at: https://cancerstatisticscenter.cancer.org/types/myeloma |
7 American Cancer Society. What is Multiple Myeloma? Accessed July 2024. Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html |
8 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Accessed July 2024. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html |
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FAQ
What is the new FDA approval for DARZALEX FASPRO® (JNJ) in multiple myeloma treatment?
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How does the new DARZALEX FASPRO® (JNJ) quadruplet therapy benefit multiple myeloma patients?
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