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Chi-Med subsidiary Hutchison Medipharma has kicked off the Phase I trial in China and has dosed its first patient with the investigational IDH inhibitor.
The final draft guidance recommends gilteritinib monotherapy for FLT3-mutated, relapsed or refractory AML, calling it a "cost-effective use of NHS resources."
The drug, designed to reactivate p53, will be evaluated in combination with chemotherapy and Venclexta as a frontline treatment for patients with TP53-mutant AML.
Of the eight patients who received drugs recommended by the tumor board based on data from the drug sensitivity assay, 75 percent responded.
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.