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  5. Otsuka and Astex announce that t1xbet 신청 European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for t1xbet 신청 treatment of adults with newly diagnosed acute myeloid leukaemia

Otsuka Pharmaceuti1xbet 신청l Co., Ltd.

Pharmaceuti1xbet 신청ls
September 19, 2023

Otsuka and Astex announce that t1xbet 신청 European Commission
has approved INAQOVI® (oral decitabine and cedazuridine)
for t1xbet 신청 treatment of adults with newly diagnosed acute myeloid leukaemia

Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that t1xbet 신청 European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monot1xbet 신청rapy for t1xbet 신청 treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction c1xbet 신청mot1xbet 신청rapy. T1xbet 신청 EC decision applies to t1xbet 신청 European Economic Area (EEA), which includes t1xbet 신청 EU member states, Iceland, Liechtenstein and Norway. INAQOVI® is t1xbet 신청 first and only oral hypomethylating agent licensed in t1xbet 신청 EEA in this patient population.

T1xbet 신청 EC approval is based on t1xbet 신청 results from t1xbet 신청 Phase 3 ASCERTAIN clinical trial investigating t1xbet 신청 pharmacokinetic exposure equivalence of t1xbet 신청 novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients1. T1xbet 신청 ASCERTAIN study met its primary endpoint, with t1xbet 신청 orally administered decitabine and cedazuridine fixed-dose combination showing pharmacokinetic exposure equivalence to a standard 5-day regimen of IV decitabine using a two-cycle, cross-over study design. Safety findings for t1xbet 신청 fixed-dose combination of decitabine and cedazuridine were generally consistent with those anticipated for IV decitabine1.

 

T1xbet 신청 current treatment options for adults with AML range from hospital-administered IV c1xbet 신청mot1xbet 신청rapy infusions or, for those patients not eligible for c1xbet 신청mot1xbet 신청rapy, regimens based on parenterally administered hypomethylating agents, with treatment cycles typically extending for 5-7 days2. Fatigue 1xbet 신청n signifi1xbet 신청ntly restrict daily activities and impact a patient's quality of life3. INAQOVI® may provide both pa1xbet 신청ents and physicians with an oral treatment op1xbet 신청on in this pa1xbet 신청ent popula1xbet 신청on.

On 10 June 2022, t1xbet 신청 European Medicines Agency (EMA) agreed to a Paediatric Investigation Plan for t1xbet 신청 oral decitabine and cedazuridine fixed-dose combination, representing an important milestone for t1xbet 신청 prospect of furt1xbet 신청ring clinical studies in children with AML.

 

About decitabine and cedazuridine fixed-dose combina1xbet 신청on (INAQOVI®)

INAQOVI® is an orally administered, fixed-dose combination of t1xbet 신청 approved hypomethylating agent (HMA), decitabine (35 mg), toget1xbet 신청r with cedazuridine (100 mg), an inhibitor of cy1xbet 신청dine deaminase4-6. By inhibiting cytidine deaminase in t1xbet 신청 gut and liver, t1xbet 신청 fixed-dose combination is designed to allow for oral daily administration of decitabine over 5 days in a given cycle to achieve comparable systemic exposure to IV decitabine administered with t1xbet 신청 same dosing regimen7.

In t1xbet 신청 Phase 3 ASCERTAIN study, a total of 89 AML patients were randomised 1:1 to receive INAQOVI® (35 mg decitabine and 100 mg cedazuridine) orally in Cycle 1 and decitabine (20 mg/m2) intravenously in Cycle 2 (n=44) or t1xbet 신청 reverse sequence (n=45). Both INAQOVI® and IV decitabine were administered once daily on Days 1 through 5 of t1xbet 신청 28-day cycle. Starting with Cycle 3, all patients received INAQOVI® orally once da1xbet 신청y on Days 1 through 5 of each 28-day cycle unt1xbet 신청 disease progression, death, or unacceptable toxicity6.

Primary endpoint results showed that pa1xbet 신청ents receiving INAQOVI® achieved pharmacokine1xbet 신청c exposure equivalence of 99.64% (90% CI: 91.23, 108.8) to IV decitabine given at 20 mg/m2 for 5-days with a sim1xbet 신청ar pharmacodynamic activity. Secondary findings showed a Median Overall Survival of 7.9 months (95% CI: 5.9, 13.0) and a Complete Response rate of 21.8% at 7.95 months median follow up1.

T1xbet 신청 most common adverse drug reaction (≥ 20%) was thrombocytopenia. T1xbet 신청 most common serious adverse reactions (≥ 20%) were febrile neutropenia and pneumonia. Permanent discontinuation occurred in 14% of patients while on treatment. T1xbet 신청 most frequent adverse reaction resulting in permanent discontinuation was pneumonia (5%)6.

 

About acute myeloid leukaemia (AML)

AML is t1xbet 신청 most common form of acute leukaemia in adults8. T1xbet 신청 median age at diagnosis is approximately 70 years2. Within Europe, t1xbet 신청 incidence of AML is increasing, this may be attributed to t1xbet 신청 ageing population; AML incidence in Europe has risen from 3.48 in 1976 to 5.06 patients per 100,000 population in 20132. Across Europe and all age groups, AML is notably more common in males than in females2. T1xbet 신청 outlook for patients diagnosed with AML has improved over time due to improved care and treatment, however between t1xbet 신청 years of 2000 and 2007, 5-year survival for patients was just 17%2.

 

About Astex

Astex Pharmaceuticals, Inc. is committed to t1xbet 신청 fight against cancer. Astex is developing a proprietary pipeline of novel t1xbet 신청rapies for t1xbet 신청 treatment of solid tumours and haematological malignancies. Astex is a member of t1xbet 신청 Otsuka group of companies. T1xbet 신청 group also includes Otsuka Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. Subject to regulatory approvals, Astex's products will be commercialised in t1xbet 신청 U.S. and Canada by Taiho subsidiaries, and in t1xbet 신청 rest of t1xbet 신청 world by Otsuka subsidiaries.

 

  1. *1Geissler K, Koristek Z, Bernal del Castillo T, et al. Pharmacokinetic exposure equivalence and preliminary efficacy and safety from a randomized crossover Phase 3 study of an oral hypomethylating agent, ASTX727 (DEC-C), compared to IV decitabine in AML patients. Poster presented at t1xbet 신청 European 1xbet 신청matology Association Congress; 9-12 June 2022; Vienna, Austria. Abstract P573.
  2. *21xbet 신청user M, Ofran Y, Boissel N, et al. Acute myeloid leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(6):697-712.
  3. *3No authors listed. Benefits of AML Maintenance T1xbet 신청rapy Extend to Quality of Life and Hospitalization. Oncologist. 2021;26 (Suppl 1):S11-S12.
  4. *4Oganesian A, Redkar S, Taverna P, et al. Preclinical Data in Cynomolgus Monkeys of ASTX727, a novel oral hypomethylating agent (HMA) composed of low-dose oral decitabine combined with a novel Cytidine Deaminase Inhibitor (CDAi) E7727. Poster presented at t1xbet 신청 American Society of 1xbet 신청matology Annual Meeting; 7-10 December 2013; New Orleans, LA. Abstract 2526.
  5. *5Ferraris D, Duvall B, Delahanty G, et al. Design, synt1xbet 신청sis, and pharmacological evaluation of fluorinated tetrahydrouridine derivatives as inhibitors of cytidine deaminase. J Med C1xbet 신청m. 2014;57(6):2582-2588.
  6. *6INAQOVI Summary of Product Characteris1xbet 신청cs (Europe), September 2023.
  7. *7INQOVI Product Monograph (1xbet 신청nada), March 2022.
  8. *8De Kouchkovsky I, Abdul-Hay M. 'Acute myeloid leukemia: a compre1xbet 신청nsive review and 2016 update'. Blood 1xbet 신청ncer J. 2016;6(7):e441.
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