The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb's Onureg (azacitidine) for the continued treatment of adults with acute myeloid leukaemia (AML).
The decision allows physicians to prescribe the drug to patients who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
In the Phase III QUAZAR AML-001 study, treatment with Onureg resulted in a statistically significant and clinically meaningful improvement in overall survival (OS), the study’s primary endpoint, of nearly 10 months versus placebo.
Median OS from time of randomisation was greater than two years among patients who received BMS' drug compared to 14.8 months among those receiving placebo.
“Continued treatment with Onureg demonstrated an overall survival benefit in adults with AML who had achieved first complete remission in the QUAZAR AML-001 study and, notably, it has the potential to do this in a convenient manner, given its once daily oral formulation,” said Andrew Wei, lead investigator on the trial, Alfred Hospital and Monash University, Melbourne, Australia.
“This approval should help establish continued treatment with Onureg as a standard component of AML therapy for adults who achieved first complete remission following chemotherapy and who cannot proceed to intensive curative therapy, like haematopoietic stem cell transplant.”