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DARZALEX Continues to Redefine Multiple Myeloma Treatment with Robust Market Performance | DelveInsight
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:
In combination with lenalidomide and dexamethasone, or with bortezomib, melphalan, and prednisone.
In combination with bortezomib, thalidomide, and dexamethasone.
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:
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 for frontline multiple myeloma transplant eligible, for frontline multiple myeloma transplant ineligible, and for smoldering multiple myeloma. In 2024, DARZALEX generated sales of across the world.
The DARZALEX dosing schedule for combination therapy (4-week cycle regimens) and monotherapy is as follows:
The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion according to the following dosing schedule:
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:
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:
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:
The recommended dosage for DARZALEX, combined with carfilzomib and dexamethasone (4-week cycle) for patients with relapsed/refractory multiple myeloma.
Learn more about DARZALEX projected market size for multiple myeloma @
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 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. 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 .
, 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 , 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 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 @
Some of the drugs in the multiple myeloma pipeline include (Bristol Myers Squibb/Celgene), and (Regeneron Pharmaceuticals), (BeiGene), (Roche), and (Arcellx), among others.
In 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 @
Discover how DARZALEX is shaping the multiple myeloma treatment landscape @
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.
Approved by the , 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 in combination with other standard-of-care therapies such as lenalidomide, bortezomib, and dexamethasone. The 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 . Its use has progressed from treating heavily pre-treated patients to frontline therapy in combination regimens, broadening its addressable patient population. with immunomodulatory agents, proteasome inhibitors, and corticosteroids have further enhanced its positioning. The 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 ( ) from Sanofi.
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 . 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 , 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. 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 @
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 among others.
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 among others.
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 among others.
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMM companies, including among others.
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