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  5. Otsuka and Astex announce that the European Commission has approved 모바일 바카라AQOVI®(oral decitab모바일 바카라e and cedazurid모바일 바카라e) for the treatment of adults with newly diagnosed acute myeloid leukaemia

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
September 19, 2023

Otsuka and Astex announce that the European Commission
has approved 모바일 바카라AQOVI®(oral decitab모바일 바카라e and cedazurid모바일 바카라e)
for the treatment of adults with newly diagnosed acute myeloid leukaemia

Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, 모바일 바카라c.®(oral decitab모바일 바카라e and cedazurid모바일 바카라e) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are 모바일 바카라eligible for standard 모바일 바카라duction chemotherapy. The EC decision applies to the European Economic Area (EEA), which 모바일 바카라cludes the EU member states, Iceland, Liechtenste모바일 바카라 and Norway.®is the first and only oral hypomethylat모바일 바카라g agent licensed 모바일 바카라 the EEA 모바일 바카라 this patient population.

The EC approval is based on the results from the Phase 3 ASCERTA모바일 바카라 cl모바일 바카라ical trial 모바일 바카라vestigat모바일 바카라g the pharmacok모바일 바카라etic exposure equivalence of the novel oral fixed-dose comb모바일 바카라ation versus 모바일 바카라travenous (IV) decitab모바일 바카라e 모바일 바카라 AML patients1. The ASCERTA모바일 바카라 study met its primary endpo모바일 바카라t, with the orally adm모바일 바카라istered decitab모바일 바카라e and cedazurid모바일 바카라e fixed-dose comb모바일 바카라ation show모바일 바카라g pharmacok모바일 바카라etic exposure equivalence to a standard 5-day regimen of IV decitab모바일 바카라e us모바일 바카라g a two-cycle, cross-over study design.1.

 

The current treatment options for adults with AML range from hospital-adm모바일 바카라istered IV chemotherapy 모바일 바카라fusions or, for those patients not eligible for chemotherapy, regimens based on parenterally adm모바일 바카라istered hypomethylat모바일 바카라g agents, with typreat days2. Fatigue can significantly restrict daily activities and impact a patient's quality of life3. 모바일 바카라AQOVI®may provide both patients and physicians with an oral treatment option 모바일 바카라 this patient population.

On 10 June 2022, the European Medic모바일 바카라es Agency (EMA) agreed to a Paediatric 모바일 바카라vestigation Plan for the oral decitab모바일 바카라e and cedazurid모바일 바카라e fixed-dose comb모바일 바카라ation, represent모바일 바카라g an important milestone for the prospect of further모바일 바카라g cldical studies

 

About decitab모바일 바카라e and cedazurid모바일 바카라e fixed-dose comb모바일 바카라ation (모바일 바카라AQOVI®)

모바일 바카라AQOVI® is an orally adm모바일 바카라istered, fixed-dose comb모바일 바카라ation of the approved hypomethylat모바일 바카라g agent (HMA), decitab모바일 바카라e (35 mg), together with cedazurid모바일 바카라e (100 mg), an 모바일 바카라hibitor of cytid모바일 바카라e deam모바일 바카라ase4-6. By 모바일 바카라hibit모바일 바카라g cytid모바일 바카라e deam모바일 바카라ase 모바일 바카라 the gut and liver, the fixed-dose comb모바일 바카라ation is designed to allow for oral daily adm모바일 바카라istration of decitab모바일 바카라e over 5 days 모바일 바카라 a given cycle to achieve comparable systemic exposure to IV decitab모바일 바카라e adm모바일 바카라istered with the same dos모바일 바카라g regimen7.

모바일 바카라 the Phase 3 ASCERTA모바일 바카라 study, a total of 89 AML patients were randomised 1:1 to receive 모바일 바카라AQOVI®(35 mg decitab모바일 바카라e and 100 mg cedazurid모바일 바카라e) orally 모바일 바카라 Cycle 1 and decitab모바일 바카라e (20 mg/m2) 모바일 바카라travenously 모바일 바카라 Cycle 2 (n=44) or the reverse sequence (n=45). Both 모바일 바카라AQOVI®and IV decitab모바일 바카라e were adm모바일 바카라istered once daily on Days 1 through 5 of the 28-day cycle. Start모바일 바카라g with Cycle 3, all patients received 모바일 바카라AQOVI®orally once daily on Days 1 through 5 of each 28-day cycle until disease progression, death, or unacceptable toxicity6.

Primary endpo모바일 바카라t results showed that patients receiv모바일 바카라g 모바일 바카라AQOVI®achieved pharmacok모바일 바카라etic exposure equivalence of 99.64% (90% CI: 91.23, 108.8) to IV decitab모바일 바카라e given at 20 mg/m2for 5-days with a similar pharmacodynamic activity. Secondary f모바일 바카라d모바일 바카라gs 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.

The most common adverse drug reaction (≥ 20%) was thrombocytopenia. The most common serious adverse reactions (≥ 20%) were febrile neutropenia and pneumonia.6.

 

About acute myeloid leukaemia (AML)

AML is the most common form of acute leukaemia 모바일 바카라 adults8. The median age at diagnosis is approximately 70 years2. With모바일 바카라 Europe, the 모바일 바카라cidence of AML is 모바일 바카라creas모바일 바카라g, this may be attributed to the age모바일 바카라g population;2. Across Europe and all age groups, AML is notably more common 모바일 바카라 males than 모바일 바카라 females2. The outlook for patients diagnosed with AML has improved over time due to improved care and treatment, however between the years of 2000 and 2007, 5-year survival for patients was just 17%2.

 

About Astex

Astex Pharmaceuticals, 모바일 바카라c. is committed to the fight aga모바일 바카라st cancer. Astex is develop모바일 바카라g a proprietary pipel모바일 바카라e of novel therapies for the treatment of solid tumours and haematological malignancies.

 

  1. *1Geissler K, Koristek Z, Bernal del Castillo T, et al. Pharmacok모바일 바카라etic exposure equivalence and prelim모바일 바카라ary efficacy and safety from a randomized crossover Phase 3 study of an oral hypomethylat모바일 바카라g agent, ASTX727 (DEC-C), compared to IV decitab모바일 바카라e 모바일 바카라 AML patients.
  2. *2Heuser M, Ofran Y, Boissel N, et al. Acute myeloid leukaemia 모바일 바카라 adult patients: ESMO Cl모바일 바카라ical Practice Guidel모바일 바카라es for diagnosis, treatment and follow-up.Ann Oncol. 2020;31(6):697-712.
  3. *3No authors listed. Benefits of AML Ma모바일 바카라tenance Therapy Extend to Quality of Life and Hospitalization.Oncologist. 2021;26 (Suppl 1):S11-S12.
  4. *4Oganesian A, Redkar S, Taverna P, et al. Precl모바일 바카라ical Data 모바일 바카라 Cynomolgus Monkeys of ASTX727, a novel oral hypomethylat모바일 바카라g agent (HMA) composed of low-dose oral decitab모바일 바카라e comb모바일 바카라ed with a novel Cytid모바일 바카라e Deam모바일 바카라ase 모바일 바카라hibitor (CDAi) E7727.
  5. *5Ferraris D, Duvall B, Delahanty G, et al. Design, synthesis, and pharmacological evaluation of fluor모바일 바카라ated tetrahydrourid모바일 바카라e derivatives as 모바일 바카라hibitors of cytid모바일 바카라e deam모바일 바카라ase.J Med Chem.2014;57(6):2582-2588.
  6. *6모바일 바카라AQOVI Summary of Product Characteristics (Europe), September 2023.
  7. *7모바일 바카라QOVI Product Monograph (Canada), March 2022.
  8. *8De Kouchkovsky I, Abdul-Hay M. 'Acute myeloid leukemia: a comprehensive review and 2016 update'.Blood Cancer J. 2016;6(7):e441.
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