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The drug, which is designed to restore normal functioning of p53, has allowed a promising proportion of TP53-mutated MDS patients to receive stem cell transplants in early trials.
The agency approved the drug based on a study that showed that Mylotarg combined with chemo extended event-free survival compared to chemo alone.
The funds from this sale of rights to Royalty Pharma will allow Agios to advance IDH inhibitors and other investigational drugs in its pipeline through clinical trials.
As MacroGenics advances flotetuzumab through AML studies, it is working with researchers to refine the predictive ability of the gene expression signature.
Glioma patients experienced tumors shrinkage, and some AML patients had a complete remission that allowed them to proceed to curative treatment.
The goal of the LLS PedAI study is to investigate the efficacy and safety of multiple precision oncology drugs at once for children with relapsed acute leukemia.
The study will compare whole-genome sequencing and RNA sequencing to conventional diagnostic methods in about 450 acute leukemia patients in Sweden.
The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.
The IPS-E prognostic tool, which draws on the presence of IGHV mutations as well as routine clinical lab tests, may also have added value in the midst of the COVID-19 pandemic.
Gilteritinib (Astellas Pharma's Xospata) is intended to treat relapsed or refractory acute myeloid leukemia patients with a FLT3 mutation.