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|Therapy Name||Daratumumab and hyaluronidase-fihj|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Daratumumab and hyaluronidase-fihj||Darzalex Faspro||Daratumumab/rHuPH20|HuMax-CD38-rHuPH20|darzalex/rHuPH20||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 for multiple myeloma patients as a monotherapy or in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, 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|
|Unknown unknown||multiple myeloma||not applicable||Daratumumab and hyaluronidase-fihj||FDA approved||Actionable||In a Phase III trial (COLUMBA) that supported FDA approval, subcutaneous administration of Darzalex Faspro (Daratumumab and hyaluronidase-fihj) demonstrated improved safety profile and resulted in an overall response rate comparable to that of intravenous Darzalex (daratumumab) (41%, 108/263, vs 37%, 96/259, relative risk 1.11) in patients with relapsed or refractory multiple myeloma who received 3 or more prior therapies (PMID: 32213342; NCT03277105).||32213342|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|