Agios Pharmaceuticals revealed in a filing with the US Securities and Exchange Commission on Wednesday that partner Celgene aims to submit the investigational therapy enasidenib for FDA approval for the treatment of relapsed and/or refractory acute myeloid leukaemia (AML) by the end of the year. Agios noted that submission of the oral IDH2 inhibitor will be supported by data from an ongoing Phase I/II study of enasidenib, also known as AG-221, in the treatment of patients with advanced IDH2-mutated haematologic malignancies. Shares in Agios surged as much as 25 percent on the news.
In the filing, Agios noted that the study consists of a dose-escalation phase and five expansion cohorts, all of which have completed accrual. In early-stage study data unveiled last year, Agios reported that 40 percent of patients with haematologic malignancies responded to enasidenib.
Separately, Agios indicated that it plans to pursue a similar regulatory path for AG-120 for the treatment of IDH1-mutated AML, potentially resulting in an FDA submission for the experimental therapy next year. For related analysis on AG-120, read ViewPoints: Amended Celgene deal raises questions about Agios’ AG-120 – but not its platform.
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