Keystone Pharmaceuticals Announces Application for Listing of New AM Drug TIBSOVO (ivosidenib)

Keystone Pharmaceuticals announced that it has submitted a third application for the listing of the new drug(http://of thenew drug(http:// of theOf Recurrent/Incuratability Acute Myeloid Leukemia (AML) to theAdministration of the FoodMedicines(http://Administration (T
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FDAof the Ministry of Health and Welfare of Taiwanit is also the first application for a new drug to be marketed since Keystone Pharmaceuticals was founded in 2015TIBSOVO is the first of its kind to be a powerful, highly selective oral mutant isocitric acid dehydrogenase-1 (IDH1) inhibitorThis product was qualified for the TFDA New Drug Priority Review on April 24, 2019Developed by Cornerstone Pharmaceuticals partner Agios Pharmaceuticals , TIBSOVO has been approved for the first time in the United States in 2018 to treat recurrent/refractory AML that carries susceptible to THE IIDH 1 gene mutation 2019, the drug's indications will be approved by the U.S FDA to be extended to newly diagnosed AML adult patients at age 75 or because of other comorbidities that cannot be used for intensive chemotherapy In addition, in response to this complementary indication, the U.S FDA has granted the "TIBSOVO Co-use Azaliline Program" breakthrough therapy designation 　　The efficacy of TIBSOVO was assessed in 174 patients with recurrent/incurable adult AML with the IDH1 mutation The starting dose of TIBSOVO is 500 mg per day orally until the disease progresses, unacceptable toxicity occurs, or hematopoietic stem cell transplantation occurs Data for Listing in the U.S tIBSOVO show that the proportion of patients with recurrent/refractory AML with an IDH1 mutation in tibibsoSOVO alone was 32.8% (57/174) (95% CI: 25.8, 40.3) and CR-CRh was 8.2 months (range 5.6, 12) 　　The safety of TIBSOVO was evaluated in 179 patients with relapse/incurable AML with the IDH1 mutation TIBSOVO is taken orally daily with a median exposure time of 3.9 months (range 0.1-39.5) In clinical trial (http:// , 19% (34/179) of patients treated with TIBSOVO developed differentiation syndrome (which can be fatal if left untreated) Patients treated with TIBSOVO also developed QTc interstitasy and Guillain-Barre syndrome The most common adverse reactions at any level of are fatigue, white blood cell enlargement, joint pain, diarrhea, dyspnea, edema, nausea, mucositis, extended period of cardiogram QT, rash, fever, cough, and constipation The most common severe adverse reactions were differentiation syndrome (10%), white blood cell growth (10%), and extended period between electrocardiogram QT (7%)