FDA grants Agios' target cancer drug Tibsovo (ivosidenib) breakthrough drug

recently, the u.Sleading cancer bio
pharmaceutical
company(http:// http://Agios announced that the U.SFood andDrug(http://Administration (
FDA(http://) has granted the targeted anti-cancer drug Tibsovo (ivosidenib) breakthrough drug (ivosidenib) breakthrough drug (Ivosidenib) to treat the treatment of isophosassine.comAbout Tibsovo
Tibsovo is an oral target inhibitor for the IDH1 enzyme, approved by the FDA in July 2018 for adult patients with a recurrent or refractory acute myeloid leukemia (R AML) confirmed by atesting (http:// method (Abbott RealTimeIDH1 accompanying diagnostic reagent (http:// box) Tibsovo is a first-in-class, selective, powerful oral target inhibitor for the heart of the IDH1 gene mutation cancer IDH1 is a metabolic enzyme with genetic mutations in a variety of tumors, including AML, bile duct cancer and glioma this approval, making Tibsovo the first drug to receive FDA approval to treat the IDH1 mutation R/R AML 　　The FDA granted Tibsovo BTD data based on a Phase I/II clinical study In the Tibsovo treatment group in the Ib section of the study, 23 patients received 500 mg doses of Tibsovo and azastine per day, with the median age of 76 years and 52% of patients aged 75 years as of august 1, 2018, the average count of neutrophils and platelets remained near or above the threshold for partial hematological recovery (CRh) Overall, 78% (18/23) of patients showed remission and 57% (13/23) achieved complete remission (CR) The median duration of CR has not yet been achieved (95% CI: 7.7, NE), and the 12-month survival rate is 82%