Latest news with #Daratumumab
Medscape
22-05-2025
- Business
- Medscape
FDA Advisory: Daratumumab Wins, Glofitamab Loses
Daratumumab and hyaluronidase (Darzalex Faspro, Johnson & Johnson) came a step closer to being approved for high-risk smoldering multiple myeloma (SMM) on Tuesday after the Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration (FDA) voted that the benefits outweigh the risks. However, the prospects of glofitamab (Columvi, Roche) for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) dimmed after the committee agreed with the FDA that the results of a trial, which was conducted largely in Asia, are not really applicable to patients in the United States. Daratumumab and hyaluronidase (DARA SC) is already on the US market as a standard first-line option for MM, but there's currently no approved medication for SMM, an MM precursor. Standard treatment for SMM is either watchful waiting or referral to a clinical trial. Glofitamab, meanwhile, has accelerated approval as monotherapy in the third or later lines for R/R DLBCL. Roche was hoping to move it to an earlier line of treatment in combination with gemcitabine and oxaliplatin for transplant-ineligible disease. The FDA called the hearing because it had concerns about the trials supporting the two applications, AQUILA in the case of DARA SC and STARGLO for glofitamab. STARGLO in the United States STARGLO evaluated substituting glofitamab for rituximab on a background of gemcitabine and oxaliplatin for transplant-ineligible R/R DLBCL, not otherwise specified, following at least one line of systemic therapy. There was a statistically significant improvement in overall survival (OS), progression-free survival (PFS), and complete response (CR) with glofitamab across 274 patients. The main concern the FDA had with the trial is that almost half of the patients were from Korea, Taiwan, and China, and there were only 25 US patients. Others came from Europe and Australia. When the FDA compared outcomes of Asian vs non-Asian patients, it found significant differences. Despite a strong hazard ratio (HR) for OS benefit in Asia (HR, 0.39), there was a trend toward worse OS in Europe and the United States and in White patients, with similar trends for worse PFS and CR rates. The reasons aren't clear. 'FDA is concerned by the lack of internal consistency observed in the STARGLO trial and how the results of the Asian region appear to be driving the overall trial results,' the agency said in meeting documents. 'The low enrollment of patients in the US limits the agency's ability to assess the applicability of the study results to a US patient population,' the FDA said in meeting documents. 'Furthermore, the FDA has identified multiple differences in patient-related, disease-related, and healthcare system–related factors between the non-Asian and Asian regional subgroup populations. Taken together, these issues raise uncertainty as to whether the results…are generalizable and applicable to a US patient population,' the agency said. Among other concerns, the FDA also noted that rituximab/gemcitabine/oxaliplatin wasn't a good comparator arm for US patients because the regimen is not commonly used in the United States, which might have contributed to low enrollment at US study sites. Trial sponsor Roche highlighted the overall outcomes and that there's an unmet need for additional DLBCL treatment options. Company representatives also said that outside of Asia, patients on glofitamab had a higher risk for disease than those on rituximab, and rituximab patients were more likely to subsequently receive new anti-lymphoma therapy like CAR T cells. It pinned the low US enrollment on COVID disruptions during the pandemic. In the end, ODAC sided with the agency, voting 8 to 1 that the trial results are not applicable to US patients. Echoing many committee members, panelist Heidi McKean, MD, community oncologist in Sioux Falls, South Dakota, said she voted that the trials wasn't applicable 'due to the inconsistencies in the results…and quite frankly, more patients in the US need to be looked at to prove efficacy and safety.' Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, said these issues in STARGLO aren't uncommon. 'Unfortunately, if you take a look at all the oncology trials that come to us, only about 20% of the population is derived from the United States. We'd like to understand the reasons why sites are not enrolling in the United States. Potentially, that could be lack of interest because many times the control arms are not appropriate for a US population,' he said. 'This is going to be an area that the Oncology Center of Excellence is looking at quite closely. People are developing drugs for marketing in the United States, so it should address our interest here in the United States,' he said. A Win for DARA SC ODAC also considered the AQUILA trial, which randomized 390 patients with SMM at a high risk for progression to MM to either DARA SC or active monitoring for up to 3 years. At a median follow-up of 65.2 months, the risk for disease progression or death was 51% lower with DARA SC than with active monitoring. At 5 years, PFS was 63.1% with DARA SC and 40.8% with active monitoring, and OS was 93.0% with DARA SC and 86.9% with active monitoring, although the trial was not adequately powered to demonstrate a significant improvement in OS. The positive results were countered by a higher incidence of grade 3/4 treatment emergent adverse events with DARA SC, 40% vs 30%. The FDA's primary concern was that the trial, which was designed almost 10 years ago, used an outdated model to select patients at high risk for progression. With current risk models, only 41% of participants would be categorized as high risk, with 39% considered intermediate risk and 20% as low risk. 'This raises concerns regarding the applicability of the trial results to a population with high-risk SMM, as currently defined,' the FDA said in meeting materials. Also, 'while the trial met its primary PFS endpoint, there is uncertainty in the benefit of delaying progression to [multiple myeloma] in the absence of a significant improvement in OS. Additionally, the observed difference in progression was primarily due to differences observed in the biochemical or lab parameters,' not the onset of symptomatic disease, the FDA said. Not all high-risk patients progress to MM, so the agency also had concerns about unnecessary treatment — particularly with the elevated risk for serious and high-grade adverse events with daratumumab. 'Given the limitations of the clinical meaningfulness of the efficacy findings and the toxicity observed with 3 years of treatment with Dara SC, there is uncertainty regarding the benefit-risk profile of Dara SC for patients with high-risk SMM,' the agency said. Johnson and Johnson countered by emphasizing that all of the trials endpoints are positive, and that without an approved medication for SMM, patients are left powerless as they wait for a MM to emerge, something a commenter likened to 'sitting on a ticking time bomb.' Vincent Rajkumar, MD, myeloma specialist at the Mayo Clinic in Rochester, Minnesota, presenting on behalf of the company, also caught the attention of panelists when he said that high-risk SMM isn't simply a benign precursor to MM, but rather cancer in itself, raising the stakes for early intervention. 'It is asymptomatic, but not premalignant. It is cancer. Genomically, [it is] indistinguishable from multiple myeloma,' he said. In the end, the company's arguments won the day. ODAC voted 6 to 2 that AQUILA provide sufficient evidence to support a favorable risk-benefit profile for DARA SC for SMM. 'The shift for me was thinking of smoldering multiple myeloma as a malignancy and allowing the physician and patient to look at this data and intervene earlier if they so choose,' McKean said. Another committee member, Christopher Lieu, MD, gastrointestinal medical oncologist at the University of Colorado Cancer Center, Aurora, Colorado, agreed. 'I really want patients and providers to have the option to discuss this, to have the benefit-risk discussion. The conversation includes the fact that there are toxicities from this drug; that there's a chance that you can prevent a life-altering fracture; that you might be able to prevent or delay at least the onset of treatment; that you might be able to delay or prevent an organ damage. I think that that is a conversation that I want patients and providers to have the option to have,' Lieu said. However, this is going to lead to overtreatment. There has to be a predictive biomarker or some type of risk stratification to refine this high-risk group,' he said. The FDA usually follows the advice of its advisory committees.
Yahoo
15-05-2025
- Business
- Yahoo
Daratumumab or Darzalex Market Research Report 2025: Epidemiology, Pipeline Analysis, Insights & Forecasts, 2019-2024, 2024-2029F, 2034F
Major players operating in the daratumumab or darzalex market are Genmab A/S, Janssen Biotech Inc. North America was the largest region in the daratumumab or darzalex market in 2024. The regions covered in daratumumab or darzalex report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the daratumumab or darzalex market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain. Dublin, May 15, 2025 (GLOBE NEWSWIRE) -- The "Daratumumab or Darzalex Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts" report has been added to Daratumumab or Darzalex market report delivers an in-depth analysis of the market's key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market. Daratumumab, also known by its brand name Darzalex, is a monoclonal antibody used in the treatment of certain cancers, primarily multiple myelomas. It is designed to target and bind to CD38, a protein highly expressed on the surface of multiple myeloma cells, as well as other malignant and normal immune cells. The growth observed during the historic period can be attributed to factors such as the adoption of multiple research channels, increased feasibility of biomanufacturing operations, higher usage of monoclonal antibodies (mAbs), a growing number of strategic initiatives, and an increase in the secretion of growth during the forecast period is driven by increasing clinical evidence supporting its effectiveness, rising adoption in earlier treatment lines, growing demand for biologics, heightened patient awareness, an increasing incidence of blood cancers, and a rising prevalence of chronic diseases. Major trends in the forecast period include technological advancements, new product launches, product and service offerings, strategic partnerships, mergers and acquisitions, innovations in radiation technologies, and increased increasing incidence of bone marrow cancers is expected to drive the growth of the daratumumab (Darzalex) market in the future. Bone marrow cancers, such as multiple myeloma and leukemia, begin in the bone marrow, causing abnormal blood cell production that disrupts normal body functions. The rise in bone marrow cancer cases can be attributed to factors like an aging population, better detection methods, and environmental, lifestyle, and genetic influences. Daratumumab (Darzalex) is used to treat multiple myeloma by targeting and eliminating abnormal plasma cells in the bone marrow. For example, in January 2024, the American Cancer Society projected 89,190 lymphoma cases and 35,780 myeloma cases, compared to 89,010 and 34,470 in 2022, respectively. This rise in bone marrow cancer incidence is driving the expansion of the daratumumab (Darzalex) growing adoption of biologics and targeted therapies is expected to further fuel the growth of the daratumumab (Darzalex) market. Targeted therapies use drugs or other substances to specifically identify and attack molecules involved in disease progression, such as cancer. The increasing use of biologics and targeted therapies is driven by the rising prevalence of chronic diseases and advancements in precision medicine, which allow for more personalized and effective treatments. Daratumumab is part of these targeted therapies, as it specifically targets CD38, a protein highly expressed on malignant plasma cells in multiple myeloma. For instance, in December 2023, the Advanced Therapy Treatment Centers (ATTC) reported a 31% increase in annual investments in advanced therapies in 2022, with the UK accounting for 14% of global commercial advanced therapy medicinal product (ATMP) clinical trials. This growing adoption of biologics and targeted therapies is contributing to the growth of the daratumumab (Darzalex) market.A key trend in the daratumumab (Darzalex) market is the shift toward early intervention strategies, such as combination therapies, to enhance the effectiveness of treating multiple myeloma and other cancers. Combination therapies use two or more drugs with different mechanisms of action to improve efficacy, reduce resistance, and potentially lower adverse effects compared to monotherapy. For example, in July 2024, Johnson & Johnson received U.S. FDA approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant (ASCT). This approval introduces a quadruplet therapy option for patients at initial diagnosis, potentially improving treatment primary types of daratumumab (Darzalex) are 100 mg injection and 400 mg injection. The 100 mg injection refers to a dose of the medication administered via injection, containing 100 milligrams (mg) of the active ingredient. These drugs are distributed through various channels, including pharmacies, hospitals, and other medical distribution networks. They are used in the treatment of conditions such as follicular lymphoma, mantle cell lymphoma, multiple myeloma, diffuse large B-cell lymphoma, and Topics Covered: 1. Executive Summary2. Daratumumab or Darzalex Market Characteristics3. Daratumumab or Darzalex Market Biologic Drug Characteristics3.1. Molecule Type3.2. Route of Administration (ROA)3.3. Mechanism of Action (MOA)3.4. Safety and Efficacy4. Daratumumab or Darzalex Market Trends and Strategies5. Daratumumab or Darzalex Market - Macro Economic Scenario Macro Economic Scenario Including the Impact of Interest Rates, Inflation, Geopolitics, and the Recovery from COVID-19 on the Market6. Global Daratumumab or Darzalex Growth Analysis and Strategic Analysis Framework6.1. Global Daratumumab or Darzalex PESTEL Analysis (Political, Social, Technological, Environmental and Legal Factors, Drivers and Restraints)6.2. Analysis of End Use Industries6.3. Global Daratumumab or Darzalex Market Growth Rate Analysis6.4. Global Daratumumab or Darzalex Historic Market Size and Growth, 2019-2024, Value ($ Billion)6.5. Global Daratumumab or Darzalex Forecast Market Size and Growth, 2024-2029, 2034F, Value ($ Billion)6.6. Global Daratumumab or Darzalex Total Addressable Market (TAM)7. Global Daratumumab or Darzalex Market Pricing Analysis & Forecasts8. Daratumumab or Darzalex Market Segmentation8.1. Global Daratumumab or Darzalex Market, Segmentation by Drug Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion 100Mg Injection 400Mg Injection 8.2. Global Daratumumab or Darzalex Market, Segmentation by Distribution Channel, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion Pharmacies Hospital Other Distribution Channels 8.3. Global Daratumumab or Darzalex Market, Segmentation by Application, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion Follicular Lymphoma Mantle Cell Lymphoma Multiple Myeloma Diffuse Large B Cell Lymphoma Other Applications 9. Global Daratumumab or Darzalex Market Epidemiology of Clinical Indications9.1. Drug Side Effects9.2. Incidence and Prevalence of Clinical Indications10. Daratumumab or Darzalex Market Regional and Country Analysis10.1. Global Daratumumab or Darzalex Market, Split by Region, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion10.2. Global Daratumumab or Darzalex Market, Split by Country, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-03-2025
- Business
- Yahoo
DARZALEX Continues to Redefine Multiple Myeloma Treatment with Robust Market Performance
DARZALEX has significant market potential as a leading monoclonal antibody for multiple myeloma treatment. Its approval in various combinations for both newly diagnosed and relapsed/refractory patients has expanded its reach. The multiple myeloma market is expected to grow steadily, with DARZALEX contributing significantly due to its strong clinical efficacy and growing adoption. LAS VEGAS, March 20, 2025 /PRNewswire/ -- DelveInsight's "DARZALEX Market Size, Forecast, and Market Insight Report" highlights the details around DARZALEX, a human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of DARZALEX. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Janssen's DARZALEX (daratumumab, JNJ-54767414) Overview DARZALEX (daratumumab) is a prescription medication used to treat multiple myeloma, a type of blood cancer. It is not a chemotherapy drug but a human IgG1k monoclonal antibody that binds strongly to the CD38 molecule, which is highly expressed in multiple myeloma cells. Daratumumab works by activating the immune system to target and destroy cancer cells, leading to rapid tumor cell death through various immune-mediated mechanisms and immunomodulatory effects. It also induces direct tumor cell death through apoptosis (programmed cell death). Janssen Biotech develops and commercializes DARZALEX under an exclusive global license from Genmab. As the first CD38-targeting monoclonal antibody, DARZALEX has received Orphan Drug and Breakthrough Therapy designations for multiple myeloma, helping to accelerate its approval process. DARZALEX is approved for the treatment of adult patients with multiple myeloma in various combinations and settings: Newly Diagnosed Patients (Ineligible for Autologous Stem Cell Transplant): In combination with lenalidomide and dexamethasone, or with bortezomib, melphalan, and prednisone. Newly Diagnosed Patients (Eligible for Autologous Stem Cell Transplant): In combination with bortezomib, thalidomide, and dexamethasone. Relapsed or Refractory Multiple Myeloma: In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy. In combination with bortezomib and dexamethasone for patients who have undergone at least one previous treatment. In combination with carfilzomib and dexamethasone for patients who have received one to three prior lines of therapy. In combination with pomalidomide and dexamethasone for patients who have undergone at least two prior therapies, including lenalidomide and a proteasome inhibitor. As Monotherapy: For patients who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or those who are double-refractory to both classes of drugs. Apart from this, DARZALEX FASPRO is a subcutaneous (SC) formulation that combines daratumumab, a CD38-targeting cytolytic antibody, with hyaluronidase, an enzyme that aids in drug absorption. It is indicated for the treatment of adult patients with multiple myeloma in various scenarios: Newly Diagnosed Patients (Ineligible for Autologous Stem Cell Transplant): In combination with bortezomib, melphalan, and prednisone. In combination with lenalidomide and dexamethasone. Newly Diagnosed Patients (Eligible for Autologous Stem Cell Transplant): In combination with bortezomib, thalidomide, and dexamethasone. Relapsed or Refractory Multiple Myeloma: In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy. In combination with bortezomib and dexamethasone for patients who have undergone at least one previous treatment. In combination with carfilzomib and dexamethasone for patients with one to three prior lines of therapy. In combination with pomalidomide and dexamethasone for patients who have received at least one prior therapy, including lenalidomide and a proteasome inhibitor. As Monotherapy: For patients who have received at least three prior therapies, including a proteasome inhibitor and an immunomodulatory agent, or those who are double-refractory to both drug classes. DARZALEX is currently being investigated in multiple clinical trials for multiple myeloma including PERSEUS for frontline multiple myeloma transplant eligible, CEPHEUS for frontline multiple myeloma transplant ineligible, and AQUILA for smoldering multiple myeloma. In 2024, DARZALEX generated sales of USD 11.6 billion across the world. Drug Name DARZALEX (daratumumab, JNJ-54767414) Molecule type Monoclonal antibody Developer Johnson & Johnson (Janssen) First Approval Year US: 2015; EU: 2016; JP: 2017 Primary Indication Adult patients with multiple myeloma Mechanism of action Binds to CD38 and inhibits the growth of CD38-expressing tumor cells Route of administration DARZALEX: IV infusion; DARZALEX FASPRO: SC injection DARZALEX Dosage and Administration Monotherapy and in combination with Lenalidomide (D-Rd) or Pomalidomide (D-Pd) and Dexamethasone The DARZALEX dosing schedule for combination therapy (4-week cycle regimens) and monotherapy is as follows: Combination therapy with lenalidomide and low-dose dexamethasone for newly diagnosed patients ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed/refractory multiple myeloma. Combination therapy with pomalidomide and low-dose dexamethasone for patients with relapsed/refractory multiple myeloma. Monotherapy for patients with relapsed/refractory multiple myeloma. The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule: Weeks Schedule Weeks 1–8 Weekly (total of eight doses) Weeks 9–24a Every 2 weeks (total of eight doses) Week 25b onwards until disease progression Every 4 weeks aFirst dose of the every-2-week dosing schedule is given at Week 9 bFirst dose of the every-4-week dosing schedule is given at Week 25 In combination with Bortezomib, Melphalan, and Prednisone (D-VMP) The DARZALEX dosing schedule for combination therapy with bortezomib, melphalan, and prednisone (6-week cycle regimen) for patients with newly diagnosed multiple myeloma ineligible for ASCT. The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule: Weeks Schedule Weeks 1–6 Weekly (total of six doses) Weeks 7–54a Every 3 weeks (total of 16 doses) Week 55b onwards until disease progression Every 4 weeks aFirst dose of the every-3-week dosing schedule is given at Week 7 bFirst dose of the every-4-week dosing schedule is given at Week 55 In Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTd) The DARZALEX dosing schedule for combination therapy with bortezomib, thalidomide, and dexamethasone (4-week cycle regimen) for patients with newly diagnosed multiple myeloma eligible for ASCT. The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule: Treatment Phase Weeks Schedule Induction Weeks 1–8 Weekly (total of 8 doses) Weeks 9–16a Every 2 weeks (total of four doses) Stop for High Dose Chemotherapy and ASCT Consolidation Week 1-8b Every 2 weeks (total of four doses) aFirst dose of the every-2-week dosing schedule is given at Week 9 bFirst dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT In combination with Bortezomib and Dexamethasone (D-Vd) The DARZALEX dosing schedule for combination therapy with bortezomib and dexamethasone (3-week cycle regimen) for patients with relapsed/refractory multiple myeloma. The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule: Weeks Schedule Weeks 1–9 Weekly (total of nine doses) Weeks 10–24a Every 3 weeks (total of five doses) Week 25b onwards until disease progression Every 4 weeks aFirst dose of the every-3-week dosing schedule is given at Week 10 bFirst dose of the every-4-week dosing schedule is given at Week 25 In combination with Carfilzomib and Dexamethasone (DKd) The recommended dosage for DARZALEX, combined with carfilzomib and dexamethasone (4-week cycle) for patients with relapsed/refractory multiple myeloma. Weeks DARZALEX Dosec Schedule Week 1 8 mg/kg Days 1 and 2 (total two doses) Weeks 2–8 16 mg/kg Weekly (total of seven doses) Weeks 9–24a 16 mg/kg Every 2 weeks (total of eight doses) Week 25b onwards until disease progression 16 mg/kg Every 4 weeks aFirst dose of the every-2-week dosing schedule is given at Week 9 bFirst dose of the every-4-week dosing schedule is given at Week 25 cBased on actual body weight Learn more about DARZALEX projected market size for multiple myeloma @ DARZALEX Market Potential Multiple myeloma is a cancer caused by the uncontrolled growth of clonal plasma cells, leading to organ dysfunction and eventually death. In 2024, the US saw over 33,000 new symptomatic cases, with moderate growth expected at a steady CAGR from 2025 to 2034. The treatment landscape for multiple myeloma is evolving rapidly, with monoclonal antibodies playing an increasingly important role, especially in newly diagnosed patients. DARZALEX has secured a strong market position over its competitors, and many emerging therapies are expected to complement rather than directly challenge it. Johnson & Johnson is actively evaluating treatment sequences combining DARZALEX with TECVAYLI, CARVYKTI, and TALVEY. SARCLISA, a newly approved CD38 antibody for multiple myeloma, is quickly gaining market share, but DARZALEX maintains a significant advantage due to its early market entry. Both drugs are competing in quadruplet regimens for both transplant-eligible and non-eligible patients, with the competition heating up in the non-transplant-eligible segment, supported by data from transplant-eligible trials. DARZALEX, developed by Johnson & Johnson, and EMPLICITI, from Bristol Myers Squibb and AbbVie, were introduced simultaneously, but DARZALEX has emerged as a blockbuster therapy, outperforming EMPLICITI in market uptake. The US multiple myeloma market was valued at USD 15 billion in 2024, with significant growth expected by 2034. This growth will be fueled by rising incidence rates, expanded indications, earlier adoption of existing therapies, increased use of innovative treatments like CAR-T and anti-BCMA therapies, pipeline developments, and greater research and development investments. Discover more about the multiple myeloma market in detail @ Multiple Myeloma Market Report Emerging Competitors of DARZALEX Some of the drugs in the multiple myeloma pipeline include Mezigdomide (Bristol Myers Squibb/Celgene), Linvoseltamab and REGN7945 (Regeneron Pharmaceuticals), BGB-11417 (BeiGene), Cevostamab (Roche), and CART-ddBCMA (Arcellx), among others. In February 2025, Regeneron Pharmaceuticals announced that the CHMP of the EMA has recommended the conditional marketing authorization of linvoseltamab for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 3 prior lines of therapy. The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with RRMM. Earlier this month, the FDA accepted for review the Biologics License Application for linvoseltamab. The target action date for the FDA decision is July 10, 2025. To know more about the number of competing drugs in development, visit @ DARZALEX Market Positioning Compared to Other Drugs Key Milestones of DARZALEX In February 2025, Johnson & Johnson's DARZALEX subcutaneous-based regimen received a positive CHMP opinion for patients with newly diagnosed multiple myeloma, regardless of transplant eligibility. In November 2024, Johnson & Johnson submitted regulatory applications to the FDA and the EMA for the approval of a new indication for DARZALEX FASPRO in the US and the DARZALEX subcutaneous (SC) formulation in the European Union (EU). In October 2024, Janssen-Cilag International NV, a Johnson & Johnson company, announced that the EC has approved an expanded indication for the SC formulation of DARZALEX. It is now approved for use in combination with bortezomib, lenalidomide, and dexamethasone in patients with NDMM who are eligible for ASCT. This approval allows patients to receive the daratumumab SC-based quadruplet therapy at the time of initial diagnosis, offering a new treatment option that has demonstrated significant improvements in patient outcomes. In November 2021, the US FDA approved DARZALEX FASPRO in combination with KYPROLIS (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In July 2021, the US FDA approved DARZALEX FASPRO in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. In June 2021, the European Commission approved DARZALEX SC in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor (PI) and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a PI and have demonstrated disease progression on or after the last therapy. In May 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending DARZALEX IV in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. In March 2021, Janssen announced the approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for the SC formulation of DARZALEX (known as DARZQURO) for the treatment of multiple myeloma In November 2020, Ono Pharmaceutical announced that an additional twice-weekly regimen has been available for KYPROLIS for IV injections of 10 mg and 40 mg (KYPROLIS), a proteasome inhibitor, in Japan, in combination with dexamethasone plus DARZALEX IV infusion for the approved indication of relapsed or refractory multiple myeloma. In August 2020, the FDA approved DARZALEX and carfilzomib in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. In June 2020, the European Commission granted marketing authorization for DARZALEX SC formulation for treating adult patients with multiple myeloma. Daratumumab SC is administered as a fixed dose, significantly reducing treatment time from hours to approximately 3–5 min, compared to the daratumumab IV formulation. In May 2020, the US FDA approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a new SC formulation of daratumumab. DARZALEX Faspro is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible, and relapsed or refractory patients. In January 2020, the European Commission granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). In December 2019, daratumumab, with a new dosage, was indicated for treating multiple myeloma. In November 2019, the European Commission granted marketing authorization for DARZALEX in combination with lenalidomide and dexamethasone (Rd) as a treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). In September 2019, DARZALEX received approval with bortezomib, thalidomide, and dexamethasone to treat newly diagnosed patients eligible for autologous stem cell transplants. In August 2019, DARZALEX was approved in combination with bortezomib, melphalan, and prednisone for treating patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant in Japan. In June 2019, DARZALEX received approval with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In February 2019, Janssen Biotech got approval from the US FDA for a split-dosing regimen for DARZALEX, providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. In December 2018, Janssen Biotech got approval from the European Commission for the marketing authorization of a split first infusion of DARZALEX over 2 consecutive days for patients with multiple myeloma. In August 2018, the European Commission granted marketing authorization for DARZALEX (daratumumab) in combination with bortezomib, melphalan, and prednisone (VMP), for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. In May 2018, DARZALEX received approval in combination with Bortezomib, Melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT), making it the first monoclonal antibody approved for newly diagnosed patients with this disease. In September 2017, the Ministry of Health, Labor and Welfare (MHLW) in Japan approved the use of DARZALEX daratumumab) in combination with lenalidomide, dexamethasone, bortezomib, and dexamethasone for treating adults with relapsed or refractory multiple myeloma. In June 2017, DARZALEX was combined with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies, including lenalidomide (an immunomodulatory agent) and a PI. In April 2017, the European Commission approved DARZALEX for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. In November 2016, DARZALEX was used in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy. In November 2016, Amgen entered into a collaboration with Janssen Biotech to evaluate the combination of Amgen's KYPROLIS (carfilzomib) and Janssen's DARZALEX (daratumumab) in multiple clinical studies in patients with multiple myeloma. Under the terms of the agreement, the companies elected to supply drugs only or supply drugs and share development costs on a study-by-study basis. In May 2016, the European Commission granted conditional approval to DARZALEX for monotherapy of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. In November 2015, DARZALEX first received US FDA approval as a monotherapy for patients with multiple myeloma 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. In July 2013, orphan designation (EU/3/13/1153) was granted by the European Commission to Janssen-Cilag International, Belgium, for Daratumumab to treat plasma-cell myeloma. In August 2012, Janssen Biotech and Genmab entered a global license and development agreement, which granted Janssen an exclusive license to develop, manufacture, and commercialize DARZALEX for patients with multiple myeloma Discover how DARZALEX is shaping the multiple myeloma treatment landscape @ DARZALEX Injection DARZALEX Patent Details The latest licensed US patent for DARZALEX is set to expire in 2029, while the latest licensed European patent will expire in 2031 or 2032. Additionally, Janssen Biotech holds a distinct patent portfolio covering DARZALEX FASPRO. DARZALEX Market Dynamics Approved by the FDA in 2015, DARZALEX has significantly changed the treatment landscape for multiple myeloma, particularly for patients who have relapsed or are refractory to prior therapies. Its market success has been driven by strong clinical efficacy, demonstrated by improved progression-free survival (PFS) and overall survival (OS) in combination with other standard-of-care therapies such as lenalidomide, bortezomib, and dexamethasone. The introduction of a subcutaneous formulation (DARZALEX FASPRO) in 2020 further strengthened its market position by offering a faster, more convenient administration option compared to the original intravenous formulation. The multiple myeloma market has seen robust growth, with DARZALEX playing a key role due to its expanding label across different lines of therapy. Its use has progressed from treating heavily pre-treated patients to frontline therapy in combination regimens, broadening its addressable patient population. Janssen's strategic partnerships and combination studies with immunomodulatory agents, proteasome inhibitors, and corticosteroids have further enhanced its positioning. The growing preference for combination therapies in multiple myeloma, supported by real-world evidence and updated treatment guidelines, has sustained strong demand for DARZALEX despite increasing competition from other CD38-targeting therapies like isatuximab (SARCLISA) from Sanofi. Pricing and reimbursement dynamics have also shaped the market landscape. DARZALEX commands a premium price, justified by its strong clinical benefits and expanded label indications. However, reimbursement challenges and pricing pressures from healthcare payers and governments, especially in Europe, have required Janssen to adopt targeted pricing and patient assistance programs. The availability of the subcutaneous version, which reduces administration time and healthcare resource utilization, has helped mitigate cost concerns and strengthen market adoption. The competitive landscape in the multiple myeloma market remains intense, with new entrants targeting CD38 and other novel mechanisms, such as BCMA-targeting therapies and T-cell engagers. However, DARZALEX has maintained a strong foothold through first-mover advantage, long-term clinical data, and established physician familiarity. Ongoing clinical trials exploring combinations with emerging agents and potential indications beyond multiple myeloma could further enhance its market longevity and competitive edge. Dive deeper to get more insight into DARZALEX's strengths & weaknesses relative to competitors @ DARZALEX Market Drug Report Table of Contents 1 Report Introduction 2 DARZALEX: Johnson & Johnson (Janssen) 2.1 Product Overview 2.2 Other Development Activities 2.3 Clinical Development 2.4 Clinical Trials Information 2.5 Safety and Efficacy 2.6 Product Profile 2.7 Market Assessment 2.7.1 The 7MM Analysis 2.7.1.1 Cost Assumptions and Rebate 2.7.1.2 Pricing Trends 2.7.1.3 Analogue Assessment 2.7.1.4 Launch Year and Therapy Uptake 2.7.2 The United States Market Analysis 2.7.3 EU4 and the United Kingdom Market Analysis 2.7.3.1 Germany 2.7.3.2 France 2.7.3.3 Italy 2.7.3.4 Spain 2.7.3.5 UK 2.7.4 Japan Market Analysis 2.8 Market Drivers 2.9 Market Barriers 2.10 SWOT Analysis 3 Key Cross of Marketed Competitors of DARZALEX 4 Key Cross of Emerging Competitors of DARZALEX Related Reports Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, among others. Relapsing Refractory Multiple Myeloma Market Relapsing Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key RRMM companies including AbbVie, Genentech, Amgen, Onyx Therapeutics Inc., Bristol-Myers Squibb, MedImmune LLC, Novartis Pharmaceuticals, Incyte Corporation, Takeda, among others. Relapsing Refractory Multiple Myeloma Pipeline Relapsing Refractory Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMM companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Sign in to access your portfolio
