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Therapy Name | Daratumumab and hyaluronidase-fihj |
Synonyms | |
Therapy Description |
Darzalex Faspro (Daratumumab and hyaluronidase-fihj) is a combination of the anti-CD38 antibody Daratumumab with hyaluronidase, which may be administered subcutaneously (PMID: 32213342). Darzalex Faspro (Daratumumab and hyaluronidase-fihj) is FDA approved as a monotherapy or in combination with lenalidomide and dexamethasone, or with pomalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with Kyprolis (carfilzomib) and dexamethasone, or with bortezomib, lenalidomide, and dexamethasone for patients with multiple myeloma, and in combination with bortezomib, cyclophosphamide and dexamethasone in patients with newly diagnosed light chain amyloidosis (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Daratumumab and hyaluronidase-fihj | Darzalex Faspro | Daratumumab/rHuPH20|HuMax-CD38-rHuPH20|darzalex/rHuPH20 | CD38 Antibody 20 | Darzalex Faspro (Daratumumab and hyaluronidase-fihj) is a combination of the anti-CD38 antibody Daratumumab with hyaluronidase, which may be administered subcutaneously (PMID: 32213342). Darzalex Faspro (Daratumumab and hyaluronidase-fihj) is FDA approved as a monotherapy or in combination with lenalidomide and dexamethasone, or with pomalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with Kyprolis (carfilzomib) and dexamethasone, or with bortezomib, lenalidomide, and dexamethasone for patients with multiple myeloma, and in combination with bortezomib, cyclophosphamide and dexamethasone in patients with newly diagnosed light chain amyloidosis (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT05807048 | Phase II | Daratumumab and hyaluronidase-fihj | Daratumumab in STK11 Mutated NSCLC | Recruiting | USA | 0 |
NCT06169215 | Phase II | Bortezomib + Daratumumab and hyaluronidase-fihj + Dexamethasone + Lenalidomide Bortezomib + Daratumumab + Dexamethasone + Lenalidomide Daratumumab and hyaluronidase-fihj Bortezomib + Daratumumab + Dexamethasone + Selinexor Bortezomib + Daratumumab and hyaluronidase-fihj + Dexamethasone + Selinexor | Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma | Recruiting | USA | 0 |
NCT05561387 | Phase III | Daratumumab and hyaluronidase-fihj + Dexamethasone + Lenalidomide Bortezomib + Dexamethasone + Lenalidomide Daratumumab and hyaluronidase-fihj Lenalidomide | Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment | Recruiting | USA | 0 |
NCT05289687 | Phase II | Daratumumab and hyaluronidase-fihj | Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL | Recruiting | USA | 0 |