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A New Multiple Myeloma Indication for Daratumumab and ...


Multiple Myeloma Resources - darzalex faspro

Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation ...

Multiple myeloma: Initial treatment - UpToDate

Outline · Four-drug regimens · - Daratumumab, bortezomib, lenalidomide, dexamethasone · - Isatuximab-based four-drug regimens · Three-drug ...

Daratumumab in multiple myeloma - Nooka - 2019 - Cancer

Daratumumab is the first CD38 monoclonal antibody to deliver unprecedented clinical responses as a single agent in heavily pretreated ...

FDA Approval: New Treatment Indication for Multiple Myeloma Drug

This is the sixth indication for daratumumab plus hyaluronidase in patients with multiple myeloma. It was first approved in 2015 and can be ...

Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma

Daratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial ...

Daratumumab-based quadruplet therapy for transplant-eligible ...

Induction therapy with a triplet regimen consisting of a proteasome inhibitor, immunomodulatory drug, and dexamethasone is standard of care for ...

Clinical efficacy of daratumumab monotherapy in patients with ...

Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. ,. J Immunol. ,. 2011. , ...

FDA Approves Daratumumab Plus VRd in Newly Diagnosed ...

The FDA has approved subcutaneous daratumumab plus VRd for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for ...

Daratumumab: a game changer in myeloma therapy - The Lancet

Appropriate clinical use of daratumumab will increase the proportion of patients with improved overall survival and possibly cure. Figure f10. Copyright © 2020 ...

FDA Approves Daratumumab Plus VRd for Newly Diagnosed ...

FDA Approves Daratumumab Plus VRd for Newly Diagnosed Multiple Myeloma ... Approval was based on results of the PHASE 3 PERSEUS, open-label, ...

FDA Approves Subcutaneous Daratumumab Regimen in Newly ...

Data from the PERSEUS trial support the FDA approval of the subcutaneous daratumumab-containing regimen in newly diagnosed multiple myeloma.

Daratumumab triplet therapies in patients with relapsed or refractory ...

Daratumumab (DARA), a monoclonal antibody targeting the CD38 cell surface receptor that is highly expressed on malignant plasma cells, is one of the most ...

daratumumab - Cancer Care Ontario

Daratumumab may worsen myelosuppression when used in combination with other chemotherapy agents for the treatment of multiple myeloma. back to top. E - Dosing.

J&J seeks new FDA approval of Darzalex Faspro myeloma combo

Should the agency approve the new regulatory request, the D-VRd combo could be used as a first-line therapy regardless of patients' transplant ...

Daratumumab for the Management of Newly Diagnosed ... - Frontiers

Daratumumab-based three-drug regimens or as single-agent are treatment options highly efficacious in relapsed/refractory multiple myeloma (RRMM) ...

Daratumumab Therapy Effective for Newly Diagnosed High-Risk ...

Darzalex (daratumumab) is a monoclonal antibody drug currently approved for both refractory and new multiple myeloma. It's available in ...

Daratumumab and Hyaluronidase-fihj–Based Quadruplet Regimen ...

Subcutaneous Darzalex Faspro was first approved by the FDA in May 2020 for indications in MM that included new diagnosis, transplant ...

Daratumumab Application in Myeloma Submitted to FDA

Daratumumab and hyaluronidase-fihj regimen (Darzalex Faspro) has shown promising results in a phase 3 study (NCT03710603) for treating newly ...

FDA Approves Darzalex Faspro as Subcutaneous Formulation for ...

... new formulation is approved for the indications ... Daratumumab and hyaluronidase-fihj is approved for the treatment of patients with multiple myeloma ...

Darzalex® Approved for Additional Indications in Multiple Myeloma

The new FDA indication also requires that daratumumab be used in combination with lenalidomide and dexamethasone, or in combination with bortezomib and ...