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|Therapy Name||Daratumumab and hyaluronidase-fihj + Dexamethasone + Lenalidomide|
|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).|
|Lenalidomide||Revlimid||IMiD-1||Revlimid (lenalidomide) is a thalidomide analog which regulates cytokine production and stimulates T cells and NK cells activity (PMID: 24328678). Revlimid (lenalidomide) is FDA approved for use in multiple myeloma, relapsed or refractory Mantle cell lymphoma, and in combination with a rituximab product in follicular lymphoma and marginal zone lymphoma (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 + Dexamethasone + Lenalidomide||FDA approved||Actionable||In a Phase II trial (PLEIADES) that supported FDA approval, Darzalex Faspro (Daratumumab and hyaluronidase-fihj) demonstrated safety and efficacy comparable to Darzalex (daratumumab) when combined with Adexone (dexamethasone) and Revlimid (lenalidomide) in patients with relapsed or refractory multiple myeloma, resulted in an objective response rate of 93.8% (61/65, complete response 21.5%) (17th International Myeloma Workshop Sep 2019, Boston, MA, US. OAB-022).||detail... detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|