BMS azacitidine tablets approved by the EU: the first first-line oral maintenance therapy for patients with AML in remission

Bristol-Myers Squibb (BMS) recently announced that the European Commission (EC) has approved Onureg (azacitidine tablets) as a first-line oral maintenance therapy for treatment after induction therapy (with or without consolidation therapy).

It is worth mentioning that Onureg is Europe's first and only one-time oral first-line maintenance therapy that can be used to treat patients with a wide range of AML subtypes in first remission

In the United States, Onureg was approved by the FDA in September 2020 for the continued treatment of adult patients with AML who were in remission for the first time, specifically: for receiving intensive induction chemotherapy to achieve complete remission (CR) for the first time or complete recovery of blood cell counts.

In terms of medication, Onureg can continue until the disease progresses or unacceptable toxicity occurs

Onureg's active pharmaceutical ingredient is CC-486 (azacitidine), which is an oral hypomethylation agent that can bind to DNA and RNA, allowing continuous epigenetic regulation due to prolonged exposure

Onureg-azacitidine chemical structure

AML is the most common type of acute leukemia

Newly diagnosed adult patients with AML can usually achieve complete remission through induction chemotherapy, but many patients will relapse and experience poor results

This approval is based on the efficacy and safety results of the pivotal Phase 3 QUAZAR AML-001 study

Andrew Wei, the lead investigator of the QUAZAR AML-001 study, said: “In the European Union, although many AML patients get remission through induction therapy, the duration of remission may be short and the risk of recurrence is still high, especially for those who are not eligible for stem cell transplantation.

QUAZAR AML-001 clinical data

QUAZAR AML-001 is an international, randomized, double-blind, placebo-controlled Phase III study.

After intensive induction chemotherapy, 81% of patients achieved CR, and 19% of patients achieved CRi

With a median follow-up of 41.

Onureg's median treatment duration was 12 cycles (1-80), and placebo was 6 cycles (1-73)

Original source: Bristol Myers Squibb Receives European Commission Approval for Onureg (azacitidine tablets) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia

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