Drug Overview
Ygalo (melphalan-flufenamide; Oncopeptides) is a cytotoxic alkylating agent that consists of melphalan conjugated to phenylalanine. By utilizing peptidases that are overexpressed in malignant cells, Ygalo undergoes intracellular cleavage and provides targeted delivery of melphalan.
Ygalo is being introduced as a novel dipeptide prodrug of the alkylating agent melphalan with a mechanism of action designed to overcome melphalan’s association with toxicities and drug resistance. Topline Phase II results (ClinicalTrials.gov identifier: NCT02963493) in heavily pre-treated multiple myeloma patients are encouraging, with an overall response rate of 30%, a clinical benefit rate of 40%, and a good safety and tolerability profile. However, data from Ygalo’s head-to-head Phase III OCEAN trial (ClinicalTrials.gov identifier: NCT03151811) against Pomalyst (pomalidomide; Celgene) will be critical in determining future uptake for heavily pre-treated relapsed/refractory patients.
Ygalo (melphalan-flufenamide; Oncopeptides) is a cytotoxic alkylating agent that consists of melphalan conjugated to phenylalanine. By utilizing peptidases that are overexpressed in malignant cells, Ygalo undergoes intracellular cleavage and provides targeted delivery of melphalan.
Ygalo is being introduced as a novel dipeptide prodrug of the alkylating agent melphalan with a mechanism of action designed to overcome melphalan’s association with toxicities and drug resistance. Topline Phase II results (ClinicalTrials.gov identifier: NCT02963493) in heavily pre-treated multiple myeloma patients are encouraging, with an overall response rate of 30%, a clinical benefit rate of 40%, and a good safety and tolerability profile. However, data from Ygalo’s head-to-head Phase III OCEAN trial (ClinicalTrials.gov identifier: NCT03151811) against Pomalyst (pomalidomide; Celgene) will be critical in determining future uptake for heavily pre-treated relapsed/refractory patients.
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