echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > Keystone Pharmaceuticals filed an Ivosidenib application

    Keystone Pharmaceuticals filed an Ivosidenib application

    • Last Update: 2021-02-28
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    Keystone Pharmaceuticals announced that it has submitted an application for the listing of ivosidenib's new drug (NDA) to the Singapore Health Science Authority (HAS) for the treatment of adults with relapsed or refractic acute myeloid leukemia (R/R AML) patients with susceptible isocric acid dehydrogenase-1 (IDH1) mutations. Ivosidenib is a powerful, highly selective, pioneering oral IDH1 inhibitor developed by Keystone Pharmaceuticals partner Agios Pharmaceuticals and approved by the FDA in July 2018 to treat adult patients with acute myeloid leukemia (AML) with susceptible IDH1 gene mutations approved by the FDA for accompanying diagnostic testing. In May 2019, the FDA approved ivosidenib's application for a new diagnostic IDH1 gene mutation for patients 75 years of age and older who are unable to use intensive chemotherapy due to other combinations.
    AML is the most common type of leukemia in adults and the disease progresses rapidly, with the vast majority of patients being elderly. In the United States, there are about 20,000 new cases each year, with a five-year survival rate of about 29%. In Singapore, the incidence rate is on the rise every year. In patients with AML, the prognostic prognosticity of old age and recurrence or recurring is poor, with about 6 to 10% of AML patients carrying IDH1 mutations.At present, the standard treatment for newly diagnosed AML patients is mainly intensive chemotherapy (IC) induction therapy, about 35% to 40% of young patients can achieve complete remission, but only about 10% of elderly patients can achieve more than 3 years of survival. Most AML patients eventually develop drug resistance or recurrence into R/R AML, follow-up clinical treatment is extremely difficult, and there is no uniform standard treatment plan internationally. With the emergence of gene sequencing, mutation analysis brings new opportunities and challenges to AML treatment.Ivosidenib is an oral targeted inhibitor of IDH1 enzymes and the only FDA-approved drug to treat IDH1 mutation R/R AML. Developed by Agios Pharmaceuticals, Keystone Pharmaceuticals has reached an exclusive partnership and licensing agreement with Agios Pharmaceuticals in 2018 to advance the clinical development and commercialization of ivosidenib in Chinese mainland, Hong Kong, Macau and Taiwan ("Greater China"). In March 2020, Keystone Pharmaceuticals and Agios Pharmaceuticals amended the agreement to extend its clinical development and commercialization licensing area from Greater China to Singapore.Dr. Jiang Ningjun, Chairman and CEO of Keystone Pharmaceuticals, said, "We are pleased to see the company successfully submit its application for the launch of a new ivosidenib drug in Singapore for the treatment of relapsed/refractory acute myeloid leukemia with the IDH1 gene mutation. This is the first time Keystone Pharmaceuticals has filed a new drug listing application outside of Greater China, which is of great significance to the company's global commercialization process. We will continue to work to enable more cancer patients to benefit from innovative anti-tumor therapies. Dr, Chief Medical Officer, Keystone Pharmaceuticals, said: "The therapeutic area of AML is facing an urgent need for drug development, especially in patients with IDH1 gene mutation R/R AML who lack effective drugs. Ivosidenib is currently the only FDA-approved AML-targeted drug for the IDH1 mutation. We sincerely hope that ivosidenib will be approved in Singapore at an early time for the benefit of this group of patients.about TIBSOVO
    ®

    ®
    TIBSOVO
    ®
    developed by Cornerstone Pharmaceuticals partner Agios Pharmaceuticals ("Agios"), was approved for the first time in the U.S. in 2018 for the treatment of recurring/refraorgable AML carrying mutations in the susceptible IDH1 gene. In 2019, the drug's allergy was approved by the FDA to be extended to new diagnostic AML adult patients who are ≥75 years old or who are unable to use intensive chemotherapy because of other combinations. In addition, in response to this complementary adaptation, the FDA has awarded the "TIBSOVO
    ®
    joint Aza cytosine program" breakthrough therapy.The efficacy
    ®
    TIBSOVO was evaluated in 174 patients with relapsed/refr treatable adult AML with IDH1 mutations. The starting dose
    ®
    TIBSOVO is 500 mg per day or so until the disease progresses, there is unacceptable toxicity, or a hematopoietic stem cell transplant is performed. Data from TIBSOVO's U.S. application show that the proportion of TIBSOVO
    ®
    single-drug treatment patients with IDH1 mutation relapsed/refracticable AML who received full or complete remission with partial hematological recovery (CR-CRh) was 32.8% (57/174) (95% CI: 25.8, 40.3), the duration of the CR-CRh is 8.2 months (range 5.6, 12).The safety of
    ®
    TIBSOVO was assessed in 179 patients with relapsed/refr treatable AML with IDH1 mutations. TIBSOVO is 500mg oral daily with a medium exposure time of 3.9 months (range 0.1-39.5). In clinical trials, 19% (34/179) of patients treated with TIBSOVO developed differentiation syndrome (which can be fatal if left untreated). The most common adverse reactions (≥20%) at any level are fatigue, increased white blood cells, joint pain, diarrhea, difficulty breathing, edema, nausea, mucositis, prolongation during electroencephalogram QT, rash, fever, cough and constipation. The most common serious adverse reactions (≥5%) were differentiation syndrome (10%), white blood cell growth (10%), and extended electroenzyme QT period (7%).In June 2018, Keystone Pharmaceuticals and Agios announced exclusive cooperation and licensing agreements for the clinical development and commercialization of TIBSOVO
    ®
    in Chinese mainland, Hong Kong, Macau and Taiwan ("Greater China"). In March 2020, Keystone Pharmaceuticals and Agios Pharmaceuticals amended their agreement to extend their clinical development and commercialization licensing area from Greater China to Singapore. (Corporate website)
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.