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Title | Darzalex Faspro (Daratumumab and hyaluronidase-fihj) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Daratumumab and hyaluronidase-fihj | Daratumumab and hyaluronidase-fihj | 0 | 4 |
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 for patients with multiple myeloma, and in combination with bortezomib, cyclophosphamide and dexamethasone in patients with newly diagnosed light chain amyloidosis (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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