FDA approves azacitidine tablets for acute myeloid leukaemia

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On September 1, 2020, the Food and Drug Administration approved azacitidine tablets (ONUREG) for continued treatment of patients with acute myeloid leukaemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.

Efficacy was investigated in QUAZAR (NCT01757535), a multi-centre, randomised, double-blind, placebo-controlled trial.

Patients (n=472) who achieved CR or CRi with intensive induction chemotherapy with or without receiving subsequent consolidation therapy were randomised 1:1 to receive Onureg 300 mg (n=238) or placebo (n=234) orally on days 1 to 14 of each 28-day cycle.

The main efficacy outcome measure was overall survival (OS).

Median OS was 24.7 months (95% CI: 18.7, 30.5) in the Onureg arm and 14.8 months (95% CI: 11.7, 17.6) in the placebo arm (HR 0.69; 95% CI: 0.55, 0.86; p=0.0009).

A subgroup analysis showed consistency in the OS benefit for patients in either CR or CRi.

Adverse reactions in ≥ 10% patients receiving Onureg were nausea, vomiting, diarrhoea, fatigue/asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, febrile neutropenia, dizziness, and pain in extremity.

The recommended Onureg dose is 300 mg orally once daily with or without food on days 1 through 14 of each 28-day cycle.

Continue Onureg until disease progression or unacceptable toxicity.


Source: FDA

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