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Ref Type
PMID
Authors
Title Darzalex Faspro (Daratumumab and hyaluronidase-fihj) FDA Drug Label
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Daratumumab and hyaluronidase-fihj Daratumumab and hyaluronidase-fihj 0 4
Drug Name Trade Name Synonyms Drug Classes Drug Description
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
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References