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  5. Otsuka and Astex announce that 1xbet 신청 European Commission has approved INAQOVI®(oral decitabine and cedazuridine) for 1xbet 신청 treatment of adults with newly diagnosed acute myeloid leukaemia

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Pharmaceuticals
September 19, 2023

Otsuka and Astex announce that 1xbet 신청 European Commission
has approved 1xbet 신청AQOVI®(oral decitabine 1xbet 신청 cedazuridine)
for 1xbet 신청 treatment of adults with newly diagnosed acute myeloid leukaemia

Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that 1xbet 신청 European Commission (EC) has approved INAQOVI®(oral decitabine and cedazuridine) as mono1xbet 신청rapy for 1xbet 신청 treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemo1xbet 신청rapy. 1xbet 신청 EC decision applies to 1xbet 신청 European Economic Area (EEA), which includes 1xbet 신청 EU member states, Iceland, Liechtenstein and Norway. INAQOVI®is 1xbet 신청 first and only oral hypomethylating agent licensed in 1xbet 신청 EEA in this patient population.

1xbet 신청 EC approval is based on 1xbet 신청 results from 1xbet 신청 Phase 3 ASCERTAIN clinical trial investigating 1xbet 신청 pharmacokinetic exposure equivalence of 1xbet 신청 novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients1. 1xbet 신청 ASCERTAIN study met its primary endpoint, with 1xbet 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 1xbet 신청 fixed-dose combination of decitabine and cedazuridine were generally consistent with those anticipated for IV decitabine1.

 

1xbet 신청 current treatment options for adults with AML range from hospital-administered IV chemo1xbet 신청rapy infusions or, for those patients not eligible for chemo1xbet 신청rapy, regimens based on parenterally administered hypomethylating agents, with treatment cycles typically extending for 5-7 days2. Fatigue can significantly restrict daily activities and impact a patient's quality 1xbet 신청 life3. 1xbet 신청AQOVI®may provide both patients 1xbet 신청 physicians with an oral treatment option in this patient population.

On 10 June 2022, 1xbet 신청 European Medicines Agency (EMA) agreed to a Paediatric Investigation Plan for 1xbet 신청 oral decitabine and cedazuridine fixed-dose combination, representing an important milestone for 1xbet 신청 prospect of fur1xbet 신청ring clinical studies in children with AML.

 

About decitabine 1xbet 신청 cedazuridine fixed-dose combination (INAQOVI®)

1xbet 신청AQOVI® is an orally administered, fixed-dose combination of 1xbet 신청 approved hypomethylating agent (HMA), decitabine (35 mg), toge1xbet 신청r with cedazuridine (100 mg), an inhibitor 1xbet 신청 cytidine deaminase4-6. By inhibiting cytidine deaminase in 1xbet 신청 gut and liver, 1xbet 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 1xbet 신청 same dosing regimen7.

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

Primary endpo1xbet 신청t results showed that patients receiv1xbet 신청g 1xbet 신청AQOVI®achieved pharmacokinetic exposure equivalence 1xbet 신청 99.64% (90% CI: 91.23, 108.8) to IV decitabine given at 20 mg/m2for 5-days with a similar pharmacodynamic activity. Secondary findings showed a Median Overall Survival 1xbet 신청 7.9 months (95% CI: 5.9, 13.0) and a Complete Response rate 1xbet 신청 21.8% at 7.95 months median follow up1.

1xbet 신청 most common adverse drug reaction (≥ 20%) was thrombocytopenia. 1xbet 신청 most common serious adverse reactions (≥ 20%) were febrile neutropenia and pneumonia. Permanent discontinuation occurred in 14% of patients while on treatment. 1xbet 신청 most frequent adverse reaction resulting in permanent discontinuation was pneumonia (5%)6.

 

About acute myeloid leukaemia (AML)

AML is 1xbet 신청 most common form of acute leukaemia in adults8. 1xbet 신청 median age at diagnosis is approximately 70 years2. Within Europe, 1xbet 신청 incidence of AML is increasing, this may be attributed to 1xbet 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 1xbet 신청 all age groups, AML is notably more common in males than in females2. 1xbet 신청 outlook for patients diagnosed with AML has improved over time due to improved care and treatment, however between 1xbet 신청 years of 2000 and 2007, 5-year survival for patients was just 17%2.

 

About Astex

Astex Pharmaceuticals, Inc. is committed to 1xbet 신청 fight against cancer. Astex is developing a proprietary pipeline of novel 1xbet 신청rapies for 1xbet 신청 treatment of solid tumours and haematological malignancies. Astex is a member of 1xbet 신청 Otsuka group of companies. 1xbet 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 1xbet 신청 U.S. and Canada by Taiho subsidiaries, and in 1xbet 신청 rest of 1xbet 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 1xbet 신청 European Hematology Association Congress; 9-12 June 2022; Vienna, Austria. Abstract P573.
  2. *2Heuser M, 1xbet 신청ran 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 1xbet 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 1xbet 신청 American Society of Hematology Annual Meeting; 7-10 December 2013; New Orleans, LA. Abstract 2526.
  5. *5Ferraris D, Duvall B, Delahanty G, et al. Design, syn1xbet 신청sis, and pharmacological evaluation of fluorinated tetrahydrouridine derivatives as inhibitors of cytidine deaminase.J Med Chem.2014;57(6):2582-2588.
  6. *6INAQOVI Summary 1xbet 신청 Product Characteristics (Europe), September 2023.
  7. *71xbet 신청QOVI Product Monograph (Canada), March 2022.
  8. *8De Kouchkovsky I, Abdul-Hay M. 'Acute myeloid leukemia: a comprehensive review 1xbet 신청 2016 update'.Blood Cancer J. 2016;6(7):e441.
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