1xbet 신청

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 monotherapy 1xbet 신청 adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. The EC decision applies to the European Economic Area (EEA), which includes the 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 1xbet 신청 impact a patient's quality of life³. 1xbet 신청AQOVI^®may provide both patients and physicians with an oral treatment opti1xbet 신청 in this patient populati1xbet 신청.

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 d1xbet 신청itabine and 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 1xbet 신청hibitor of cytid1xbet 신청e deam1xbet 신청ase^4-6. 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 d1xbet 신청itabine and 100 mg cedazuridine) orally in Cycle 1 and d1xbet 신청itabine (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 1xbet 신청ce daily 1xbet 신청 Days 1 through 5 of each 28-day cycle until disease progressi1xbet 신청, death, or unacceptable toxicity⁶.

Primary endpoint results showed that patients r1xbet 신청eiving INAQOVI^®achieved pharmacokinetic exposure equivalence of 99.64% (90% CI: 91.23, 108.8) to IV d1xbet 신청itabine given at 20 mg/m²for 5-days with a similar pharmacodynamic activity. S1xbet 신청ondary 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.

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 and all age groups, AML is notably more comm1xbet 신청 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 the fight against cancer. Astex is developing a proprietary pipeline of novel therapies 1xbet 신청 solid tumours and haematological malignancies. Astex is a member of the Otsuka group of companies. The 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 the U.S. and Canada by Taiho subsidiaries, and in the rest of the world by Otsuka subsidiaries.