Oral Azacitidine Wins FDA Recognition of AML

WASHINGTON — The FDA current an oral formula of azacitidine (Onureg) for continued therapy of adults with acute myeloid leukemia (AML) in first remission nevertheless unable to continue intensive therapy.

Supporting knowledge for the approval came primarily from the pivotal phase III QUAZAR AML-001 trial, which confirmed practically a 10-month development in general survival (OS) when patients bought oral azacitidine apart from placebo after induction therapy.

“This approval need to encourage set continued therapy with Onureg as a worn component of AML therapy for adults who performed first whole remission following chemotherapy and who cannot proceed to intensive curative therapy, like hematopoietic stem-cell transplant,” main investigator Andrew Wei, MD, PhD, of Monash College in Melbourne, Australia, talked about in a assertion from Bristol Myers Squibb.

QUAZAR AML-001 incorporated patients age 55 or older with AML in first whole remission (including whole remission with incomplete blood count recovery) following induction chemotherapy nevertheless unable to continue potentially curative intensive therapy. Sufferers bought oral azacitidine or placebo and remained on therapy till illness progression or construction of unacceptable toxicity.

Facts prognosis incorporated 472 patients, and the first endpoint used to be OS from randomization. Sufferers treated with oral azacitidine had a median OS of 24.7 months as when compared with 14.8 months with placebo. The distinction represented a 31% low cost in the survival hazard in desire of oral azacitidine (95% CI 0.55-0.86, P=0.0009). A subgroup prognosis confirmed a fixed abet despite whether or no longer patients performed whole hematologic recovery.

Essentially the most extraordinary (?10% of patients) negative events among patients treated with oral azacitidine had been nausea, vomiting, diarrhea, fatigue/asthenia, constipation, pneumonia, belly ache, arthralgia, diminished appetite, febrile neutropenia, dizziness, and extremity ache. Indispensable negative reactions going down in ?2% of patients incorporated pneumonia (8%) and febrile neutropenia (7%). One lethal negative reaction (sepsis) occurred in a affected person treated with oral azacitidine.