CStone receives approval in China to initiate ivosidenib Phase I bridging registrational study for the treatment of IDH1 mutant relapsed or refractory AML
(WorldNews Health)

SUZHOU, China, July 22, 2019 /PRNewswire/ -- CStone Pharmaceuticals (`CStone`; HKEX: 2616) announced today that it has received approval from China National Medical Products Administration (NMPA) to initiate a Phase I bridging registrational study of ivosidenib (TIBSOVO) for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation. This stand-alone trial is designed to evaluate the efficacy, safety and pharmacokinetics of ivosidenib in Chinese patients with IDH1 mutant R/R AML. AML is the most common type of acute leukemia in adults and is characterized by rapid disease progression. There are approximately 20,000 new cases of AML in the U.S. each year,...