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CStone announces positive registrational study of the first-in-class drug ivosidenib in Chinese patients with relapsed or refractory acute myeloid leukemia, and NDA has been accepted by the China...

Ivosidenib (TIBSOVOA®, the brand name in the U.S.) is the first isocitrate dehydrogenase 1 (IDH1) inhibitor in China that has demonstrated its efficacy and manageable safety in patients with relapsed or refractory acute myeloid leukemia (R/R AML)



The National Medical Products Administration (NMPA) of China has accepted the new drug application (NDA) of TIBSOVOA® (ivosidenib tablets) for the treatment of adults with R/R AML with a susceptible IDH1 mutation and this NDA has been considered for priority review

SUZHOU, China, Aug. 3, 2021 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced that the China registrational study CS3010-101 of TIBSOVOA® (ivosidenib tablets) has met the pre-specified endpoints in Chinese patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible IDH1 mutation. The results demonstrated efficacy and manageable safety of TIBSOVOA® (ivosidenib tablets), which were consistent with previously reported data from the global study population. Detailed data of this registrational study will be reported at an international academic conference in the near future. Meanwhile, CStone announced that the National Medical Products Administration (NMPA) of China has accepted the new drug application (NDA) of TIBSOVOA® (ivosidenib tablets) in adult patients with R/R AML who have a susceptible IDH1 mutation and this NDA has been considered for priority review. A Professor Wang Jianxiang from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, the principal investigator of the CS3010-101 study, said, "In the field of AML treatment, we are facing urgent clinical treatment needs, especially for R/R AML patients with a susceptible IDH1 mutation, currently there is no targeted therapy available on the market in China. Congratulations on the success of the registrational study of TIBSOVOA® (ivosidenib tablets) in Chinese patients with R/R AML and we look forward to its early approval and launch in China, which will bring new hope for AML patients."Dr. Jason Yang, Chief Medical Officer of CStone, said, "We are glad that TIBSOVOA® (ivosidenib tablets) demonstrated efficacy and manageable safety in Chinese patients with R/R AML. TIBSOVOA® (ivosidenib tablets) is our fourth product with an NDA, after GAVRETOA®, AYVAKITA®, and sugemalimab, bringing the total number of our NDAs or sNDAs to seven. We will work closely with the NMPA, aiming to make this innovative drug available to Chinese patients as soon as possible."In 2020, TIBSOVOA® (ivosidenib tablets) was selected in the list of theA third batchA ofA Overseas New Drugs Urgently Needed In Clinical Settings by the Center for Drug Evaluation, NMPA, and granted for fast-track designation. As a potent and highly selective first-in-class oral IDH1 inhibitor, TIBSOVOA® (ivosidenib tablets) was also recommended by the 2020 edition of the CSCO Guidelines for Diagnosis and Treatment of Hematological Malignancies due to its proven clinical advantages.
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