More than half of patients maintained minimal residual disease (MRD) negativity (10-5) with DARZALEX FASPRO® for 24 months or longer in the Phase 3 PERSEUS study
Data from Phase 3 CEPHEUS study show 60 percent overall MRD negativity (10−5) and improved PFS with DARZALEX FASPRO® in transplant-ineligible newly diagnosed patients
CHICAGO, CA, USA I June 3, 2025 I Johnson & Johnson (NYSE: JNJ) today announced data from two studies highlighting that a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2,3 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
New analysis from the Phase 3 PERSEUS study shows the addition of DARZALEX FASPRO® to bortezomib, lenalidomide and dexamethasone (D-VRd), followed by an investigational maintenance regimen of DARZALEX FASPRO® with lenalidomide (D-R), led to improved and deepened rates of overall and sustained MRD negativity (10-5), defined as no cancer cells detected within 100,000 bone marrow cells) for at least 24 months, compared to VRd induction and consolidation with R maintenance. More than half of patients who received the DARZALEX FASPRO®-based regimen achieved sustained MRD negativity for 24 or more months and more than two-thirds of patients achieved sustained MRD-negativity at 12-months, showing 95.3 percent PFS at 48-months (95 percent confidence interval [CI], 0.3-2.3)—reinforcing the ability of DARZALEX FASPRO® to delay disease progression or death.1
“The data show that D-VRd followed by an investigational D-R maintenance regimen is a highly effective treatment option for transplant-eligible patients with newly diagnosed multiple myeloma,” said Philippe Moreau*, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France and presenting author. “The depth and durability of MRD negativity observed—paired with unprecedented progression-free survival at four years—underscore the long-term benefit the DARZALEX FASPRO-based regimen can offer patients early in their treatment journey.”
At a median follow-up of 47.5 months, 24-month sustained MRD negativity rates at the 10⁻⁵ sensitivity threshold were more than double with D-VRd followed by investigational D-R maintenance (55.8 percent), compared to VRd followed by R maintenance (22.6 percent) (odds ratio [OR]=4.36; 95 percent CI, 3.15-6.05; P<0.0001). Similarly, MRD negativity at 12 months was higher with D-VRd and D-R maintenance at 64.8 percent compared to VRd and R maintenance (29.7 percent) (OR=4.42, 95 percent CI, 3.22-6.08, P<0.0001).1
Additional data from Phase 3 CEPHEUS study explore the benefits of DARZALEX FASPRO® in transplant-ineligible patients across cytogenetic risk status
The post-hoc analysis of the Phase 3 CEPHEUS study focused exclusively on transplant-ineligible patients, reinforcing that adding DARZALEX FASPRO® to VRd significantly deepens response and prolongs PFS compared to VRd alone, even in patients who are older and considered frail by the Myeloma Geriatric Assessment score.
At a median follow-up of 58.7 months, patients receiving D-VRd achieved markedly higher overall MRD negativity rates at the 10⁻⁵ sensitivity threshold with 60.4 percent versus 39.3 percent with VRd (OR 2.37; 95 percent CI, 1.47–3.80; P=0.0004). Furthermore, treatment with D-VRd resulted in high MRD-negativity rates at the 10⁻⁶ threshold (no cancer cells detected within 1,000,000 bone marrow cells) with 45.8 percent compared to 26.9 percent with VRd (OR 2.28; 95 percent CI, 1.40–3.73; P=0.0010). These deeper responses translated into improved long-term outcomes, with 69 percent of patients remaining progression free at 54-months when treated with D-VRd versus 48.0 percent with VRd (hazard ratio [HR] 0.51; 95 percent CI, 0.35–0.74). Overall survival (OS) numerically favored D-VRd (HR 0.66; 95 percent CI, 0.42–1.03), with an even greater benefit observed after censoring for COVID-19-related deaths (HR 0.55; 95 percent CI, 0.34–0.90).2
Additional data presented at ASCO included a subgroup analysis of the CEPHEUS trial for both transplant-ineligible and deferred NDMM patients who were considered high-risk for cytogenetic abnormalities (Abstract #7529). At a median follow-up of 58.7 months, overall MRD negativity rate was improved for patients with standard risk in D-VRd versus VRd. Rates by treatment arm in patients at high risk were comparable.3
“Across multiple studies, the growing body of data on DARZALEX-based regimens indicates impressive, deep responses and meaningful progression-free survival in patients with newly diagnosed multiple myeloma, including high risk,” Jordan Schecter, MD, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “These consistent results across patient populations, regardless of transplant eligibility, reinforce the role of DARZALEX FASPRO as a cornerstone of frontline therapy.”
In the PERSEUS and CEPHEUS studies, the safety profiles were consistent with the known safety profile for DARZALEX FASPRO®.
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 Europe and Australia.
About the CEPHEUS Study
CEPHEUS (NCT03652064) is an ongoing, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of D-VRd versus 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 overall MRD negativity rate at 10-5 sensitivity threshold. Secondary endpoints include CR or better rates, PFS, sustained MRD negativity rates for ≥12 months, MRD-negative rate at one year, overall response rates, 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 Multiple Myeloma
Multiple myeloma (MM) is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.4 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.5 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.6 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.7 People with multiple myeloma have a 5-year survival rate of 59.8 percent. 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.8,9
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 MM, four of which are for frontline treatment in newly diagnosed patients who are transplant-eligible or ineligible.3,6 It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20, 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.9
DARZALEX® is the first CD38-directed antibody approved to treat MM.9 DARZALEX®-based regimens have been used in the treatment of more than 618,000 patients worldwide.
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 MM:
- 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 MM 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 MM 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
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 MM:
- 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 MM 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 MM 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
Please click here to see the full Prescribing Information.
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.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc., and Janssen Global Services, LLC are Johnson & Johnson companies.
* Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
1 Moreau, P., et al. Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.
2 Facon, T., et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of transplant-ineligible (TIE) patients in the Phase 3 CEPHEUS study. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.
3 Bahlis, N., et al. Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysis. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.
4 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
5 National Cancer Institute. Plasma Cell Neoplasms. Accessed August 2024. Available at: https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq
6 Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed August 2024. Available at: https://www.cancercenter.com/cancer-types/multiple-myeloma
7 American Cancer Society. Myeloma Cancer Statistics. Accessed August 2024. Available at: https://cancerstatisticscenter.cancer.org/types/myeloma
8 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
9 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
SOURCE: Johnson & Johnson
Post Views: 962
More than half of patients maintained minimal residual disease (MRD) negativity (10-5) with DARZALEX FASPRO® for 24 months or longer in the Phase 3 PERSEUS study
Data from Phase 3 CEPHEUS study show 60 percent overall MRD negativity (10−5) and improved PFS with DARZALEX FASPRO® in transplant-ineligible newly diagnosed patients
CHICAGO, CA, USA I June 3, 2025 I Johnson & Johnson (NYSE: JNJ) today announced data from two studies highlighting that a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2,3 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
New analysis from the Phase 3 PERSEUS study shows the addition of DARZALEX FASPRO® to bortezomib, lenalidomide and dexamethasone (D-VRd), followed by an investigational maintenance regimen of DARZALEX FASPRO® with lenalidomide (D-R), led to improved and deepened rates of overall and sustained MRD negativity (10-5), defined as no cancer cells detected within 100,000 bone marrow cells) for at least 24 months, compared to VRd induction and consolidation with R maintenance. More than half of patients who received the DARZALEX FASPRO®-based regimen achieved sustained MRD negativity for 24 or more months and more than two-thirds of patients achieved sustained MRD-negativity at 12-months, showing 95.3 percent PFS at 48-months (95 percent confidence interval [CI], 0.3-2.3)—reinforcing the ability of DARZALEX FASPRO® to delay disease progression or death.1
“The data show that D-VRd followed by an investigational D-R maintenance regimen is a highly effective treatment option for transplant-eligible patients with newly diagnosed multiple myeloma,” said Philippe Moreau*, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France and presenting author. “The depth and durability of MRD negativity observed—paired with unprecedented progression-free survival at four years—underscore the long-term benefit the DARZALEX FASPRO-based regimen can offer patients early in their treatment journey.”
At a median follow-up of 47.5 months, 24-month sustained MRD negativity rates at the 10⁻⁵ sensitivity threshold were more than double with D-VRd followed by investigational D-R maintenance (55.8 percent), compared to VRd followed by R maintenance (22.6 percent) (odds ratio [OR]=4.36; 95 percent CI, 3.15-6.05; P<0.0001). Similarly, MRD negativity at 12 months was higher with D-VRd and D-R maintenance at 64.8 percent compared to VRd and R maintenance (29.7 percent) (OR=4.42, 95 percent CI, 3.22-6.08, P<0.0001).1
Additional data from Phase 3 CEPHEUS study explore the benefits of DARZALEX FASPRO® in transplant-ineligible patients across cytogenetic risk status
The post-hoc analysis of the Phase 3 CEPHEUS study focused exclusively on transplant-ineligible patients, reinforcing that adding DARZALEX FASPRO® to VRd significantly deepens response and prolongs PFS compared to VRd alone, even in patients who are older and considered frail by the Myeloma Geriatric Assessment score.
At a median follow-up of 58.7 months, patients receiving D-VRd achieved markedly higher overall MRD negativity rates at the 10⁻⁵ sensitivity threshold with 60.4 percent versus 39.3 percent with VRd (OR 2.37; 95 percent CI, 1.47–3.80; P=0.0004). Furthermore, treatment with D-VRd resulted in high MRD-negativity rates at the 10⁻⁶ threshold (no cancer cells detected within 1,000,000 bone marrow cells) with 45.8 percent compared to 26.9 percent with VRd (OR 2.28; 95 percent CI, 1.40–3.73; P=0.0010). These deeper responses translated into improved long-term outcomes, with 69 percent of patients remaining progression free at 54-months when treated with D-VRd versus 48.0 percent with VRd (hazard ratio [HR] 0.51; 95 percent CI, 0.35–0.74). Overall survival (OS) numerically favored D-VRd (HR 0.66; 95 percent CI, 0.42–1.03), with an even greater benefit observed after censoring for COVID-19-related deaths (HR 0.55; 95 percent CI, 0.34–0.90).2
Additional data presented at ASCO included a subgroup analysis of the CEPHEUS trial for both transplant-ineligible and deferred NDMM patients who were considered high-risk for cytogenetic abnormalities (Abstract #7529). At a median follow-up of 58.7 months, overall MRD negativity rate was improved for patients with standard risk in D-VRd versus VRd. Rates by treatment arm in patients at high risk were comparable.3
“Across multiple studies, the growing body of data on DARZALEX-based regimens indicates impressive, deep responses and meaningful progression-free survival in patients with newly diagnosed multiple myeloma, including high risk,” Jordan Schecter, MD, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “These consistent results across patient populations, regardless of transplant eligibility, reinforce the role of DARZALEX FASPRO as a cornerstone of frontline therapy.”
In the PERSEUS and CEPHEUS studies, the safety profiles were consistent with the known safety profile for DARZALEX FASPRO®.
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 Europe and Australia.
About the CEPHEUS Study
CEPHEUS (NCT03652064) is an ongoing, multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of D-VRd versus 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 overall MRD negativity rate at 10-5 sensitivity threshold. Secondary endpoints include CR or better rates, PFS, sustained MRD negativity rates for ≥12 months, MRD-negative rate at one year, overall response rates, 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 Multiple Myeloma
Multiple myeloma (MM) is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.4 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.5 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.6 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.7 People with multiple myeloma have a 5-year survival rate of 59.8 percent. 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.8,9
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 MM, four of which are for frontline treatment in newly diagnosed patients who are transplant-eligible or ineligible.3,6 It is the only subcutaneous CD38-directed antibody approved to treat patients with MM. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20, 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.9
DARZALEX® is the first CD38-directed antibody approved to treat MM.9 DARZALEX®-based regimens have been used in the treatment of more than 618,000 patients worldwide.
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 MM:
- 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 MM 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 MM 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
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 MM:
- 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 MM 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 MM 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
Please click here to see the full Prescribing Information.
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.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc., and Janssen Global Services, LLC are Johnson & Johnson companies.
* Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.
1 Moreau, P., et al. Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.
2 Facon, T., et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of transplant-ineligible (TIE) patients in the Phase 3 CEPHEUS study. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.
3 Bahlis, N., et al. Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): Phase 3 CEPHEUS trial cytogenetic subgroup analysis. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.
4 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
5 National Cancer Institute. Plasma Cell Neoplasms. Accessed August 2024. Available at: https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq
6 Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed August 2024. Available at: https://www.cancercenter.com/cancer-types/multiple-myeloma
7 American Cancer Society. Myeloma Cancer Statistics. Accessed August 2024. Available at: https://cancerstatisticscenter.cancer.org/types/myeloma
8 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
9 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
SOURCE: Johnson & Johnson
Post Views: 962
