daratumumab for multiple myeloma

It is easy to be overwhelmed by hype in cancer research, with promising new discoveries often portrayed as so-called game changers.1 Most new treatments for cancer are far from being transformative, but daratumumab is possibly a rare exception. It targets CD38, an antigen that is uniformly expressed in myeloma cells.2 As the most anticipated new drug in multiple myeloma in more than a decade

Now as we are close to the 10-year anniversary of dosing the first patient with daratumumab (March 26, 2008), it seems appropriate to review how far we have come in the development of this CD38 antibody for the treatment of multiple myeloma. Based

The US Food and Drug Administration has announced its approval of daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide and dexamethasone in newly diagnosed patients who are eligible

Darzalex (daratumumab) is a human CD38-directed monoclonal antibody used to treat multiple myeloma 1,3,8. Who is Darzalex (daratumumab) for? Darzalex (daratumumab) is indicated for patients with: newly diagnosed multiple myeloma

1. Perrot A, Faco T, Plesner T, et al. Faster and sustained improvement in health-related quality of life (HRQoL) for newly diagnosed multiple myeloma (NDMM) patients ineligible for transplant treated with daratumumab, lenalidomide, and dexamethasone (D.

Daratumumab in front-line multiple myeloma Given the impressive results in second-line, investigators sought to evaluate daratumumab in front-line therapy for multiple myeloma. Front-line treatment includes bortezomib, a proteasome inhibitor that is especially

FDA Approves Darzalex (Daratumumab) for Multiple Myeloma Written By:Stacy Simon November 17, 2015 The US Food and Drug Administration (FDA) has approved the first monoclonal antibody to treat people with multiple myeloma , a type of cancer that starts in plasma cells.

PDF | This mini-review will summarize the present state of development of the CD38 antibody daratumumab for the treatment of multiple In multiple myeloma (MM), MCL

The United States Food and Drug Admin istra tion (FDA) has approved dara tumu mab for the treat ment of multiple myeloma. The drug will be mar keted under the brand name Darzalex.It is ex pec ted to be avail able at U.S. treat ment centers and doctor’s offices within

Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles

The 3-drug regimen should be considered a new standard of care. The 61% improvement in PFS is “unprecedented in randomized studies that compare novel treatments for relapsed or refractory multiple myeloma,” reported Antonio Palumbo, MD. Stay up to date on

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daratumumab for the treatment of multiple myeloma. Keywords: daratumumab, myeloma, CD38, immunomodulation, adenosine, complement, trogocytosis, neonatal Fc

“I honestly don’t think anybody really knows why exactly daratumumab and elotuzumab — the 2 U.S. Food and Drug Administration-approved onco-antibodies for multiple myeloma — worked out

The US Food and Drug Administration (FDA) has approved daratumumab (DARZALEX) combination regimen for the treatment of newly diagnosed, autologous stem cell transplant (ASCT)-eligible patients with multiple myeloma. The monoclonal antibody from Janssen

Kenneth Anderson, MD, explains the mechanisms of action for two new monoclonal antibodies, elotuzumab and daratumumab, currently under investigation for the treatment of multiple myeloma.

Janssen Biotech is planning a new Phase 3 clinical trial to explore a combination of under-the-skin daratumumab plus Revlimid (lenalidomide) as a maintenance treatment for multiple myeloma patients who received an autologous stem cell transplant as front-line treatment.

Daratumumab (Dara) is the first-in-class human-specific anti-CD38 mAb approved for the treatment of multiple myeloma (MM). Although recent data have demonstrated very promising results in clinical practice and trials, some patients do not achieve a partial

Daratumumab is the first CD38 monoclonal antibody to deliver unprecedented clinical responses as a single agent in heavily pretreated patients with myeloma, and this had led to several US Food and Dr

Based on findings from the phase Ib EQUULEUS (MMY1001) trial, a split-dosing regimen of daratumumab has been approved by the FDA for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed

Daratumumab is moving from a monotherapy for relapsed and refractory myeloma to a potential frontline player in combination induction regimens. And on the horizon are investigational bispecific

Treatment of multiple myeloma in the CASTOR clinical trial of Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma In August 2016, Antonio Palumbo from the Department of Hematology in Turin, Italy, and a wide group of collaborators, published the findings of the CASTOR clinical trial – to assess the efficacy of daratumumab

CASTOR showed the significant clinical benefit of daratumumab plus bortezomib and dexamethasone for patients with previously treated multiple myeloma. With ∼3 years median follow-up, this regimen continues to demonstrate significantly improved

User Reviews for Daratumumab to treat Multiple Myeloma Also known as: Darzalex The following information is NOT intended to endorse any particular medication. While these reviews might be helpful, they are not a substitute for the expertise, skill, knowledge and

The triplet combination of bortezomib, cyclophosphamide and dexamethasone (VCd) has been found to be well-tolerated and provide high response rates in patients with newly diagnosed multiple myeloma (NDMM) making it a suitable option for induction therapy in

The first monoclonal antibody for use in multiple myeloma, daratumumab (Darzalex), has just been approved by the FDA. “These are patients who otherwise have very few, if any, good treatment

19/6/2017 · The FDA approved daratumumab in combination with pomalidomide and dexamethasone for the third-line treatment of patients with multiple myeloma. The US Food and Drug Administration (FDA) approved

A supplemental Biologics License Application for daratumumab in combination with carfilzomib and dexamethasone was submitted to the FDA for consideration as treatment for relapsed/refractory multiple myeloma, according to a press release from Janssen

FDA approval history for Darzalex (daratumumab) used to treat Multiple Myeloma. Supplied by Janssen Biotech, Inc. Darzalex Approval History Reviewed by J.Stewart BPharm Last updated on Sep 30, 2019.FDA Approved: Yes (First approved November 16, 2015)

Daratumumab, a human IgG1κ monoclonal antibody that targets the cell surface protein CD38, demonstrates on-tumor and immunomodulatory mechanisms of action in multiple myeloma (MM) 1,2,3,4,5,6.

Project Number pCODR 10079 Brand Name Darzalex Generic Name Daratumumab Strength 100mg/5mL and 400mg/20mL Tumour Type Myeloma Indication Multiple Myeloma Funding Request For the treatment of patients with multiple myeloma who 1) have

Klyuchnikov E, von Pein UM, Ayuk FA, Christopeit M, Adjalle R, van Randenborgh A, et al. Daratumumab is an effective and safe salvage therapy in relapsed/refractory patients with multiple myeloma

Report from phase II, open-label CENTAURUS study investigating the efficacy and safety of three daratumumab dosing schedules for patients with smoldering multiple myeloma Secondary efficacy endpoints OS data are immature; follow-up is ongoing Median PFS

Multiple myeloma is a cancer of the bone marrow plasma cells. It is synonymous with “myeloma” and “plasma cell myeloma.” Plasma cells make antibodies against infectious agents such as viruses and bacteria. A cancerous or malignant plasma cell is called a

Conclusions Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free

Results of the MMY3003 and MMY3004 trials established that daratumumab can be combined synergistically with some of the most highly active agents used to treat multiple myeloma, leading to

The FDA approved a split-dosing regimen for daratumumab that will allow the first infusion to be administered over two consecutive days for patients with multiple myeloma

The FDA has approved daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous

If your doctor tells you that you’re having a relapse, it means your multiple myeloma came back after your treatment left you cancer-free for a while. Learn the symptoms, causes

BACKGROUND: Daratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in

CHICAGO ― A novel investigational agent has produced unprecedented responses when used as monotherapy in patients heavily treated with multiple myeloma. The drug, daratumumab, is a novel anti

Multiple myeloma is a cancer of the bone marrow plasma cells. It is synonymous with “myeloma” and “plasma cell myeloma.” Plasma cells make antibodies against infectious agents such as viruses and bacteria. A cancerous or malignant plasma cell is called a

30/3/2020 · Subcutaneous daratumumab, a monoclonal antibody was determined to be non-inferior to FDA approved intravenous daratumumab in terms of efficacy and pharmacokinetics as treatment of patients with relapsed or refractory multiple myeloma, according to results

Daratumumab (Dara) is the first-in-class human-specific anti-CD38 mAb approved for the treatment of multiple myeloma (MM). Although recent data have demonstrated very

Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis Results from the Randomized, Open-Label, Phase 3 Study Candor

27/3/2020 · An updated analysis from the ALCYONE trial has found that adding daratumumab (Darzalex) to a standard-of-care regimen significantly prolonged survival in patients with transplant-ineligible multiple myeloma, according to a recent paper in The Lancet. Newly diagnosed patients who received daratumumab

Daratumumab is a human immunoglobulin G1κ monoclonal antibody directed against cluster of differentiation (CD) 38 that received US Food and Drug Administration approval in 2017 as multiple myeloma therapy. Citation Khan S, Vaisman A, Hota SS, et al. Listeria Susceptibility in Patients With Multiple Myeloma Receiving Daratumumab-Based Therapy.

The daratumumab, lenalidomide, and dexamethasone triplet is a new frontline option for patients with multiple myeloma who are not candidates for transplant, but how practice-changing are the data

Multiple myeloma (MM), also known as plasma cell myeloma, is a cancer of plasma cells, a type of white blood cell that normally produces antibodies.[5] Often, no symptoms are noticed initially.[1] As it progresses, bone pain, bleeding, frequent infections, and anemia may occur.[1] Complications may include amyloidosis.[2] The cause of multiple

Signs and symptoms ·
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JOURNAL OF CLINICAL ONCOLOGY REVIEW ARTICLE How to Integrate Elotuzumab and Daratumumab Into Therapy for Multiple Myeloma Craig C. Hofmeister and Sagar Lonial ABSTRACT Purpose Treatment options and outcomes for patients with multiple

22/8/2019 · Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab