The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion of azacitidine (Onureg) for use as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved a first complete remission.
The recommendation for marketing authorization also includes use in patients who have achieved complete remission with incomplete blood count recovery after induction chemotherapy (with or without consolidation treatment) and who are unable to proceed to hematopoietic stem cell transplantation.
Azacitidine will be available as 200-mg and 300-mg film-coated tablets. The drug exerts its antineoplastic effects by multiple mechanisms, including cytotoxicity on cells in the bone marrow and hypomethylation of DNA, the EMA says.
“The benefit of Onureg is its ability to improve the overall survival,” the organization also states about the product, which is made by Bristol-Myers Squibb Pharma EEIG.
Azacitidine significantly improved overall survival when compared with placebo in the QUAZAR AML-001 trial, shelf life of nexium which was the basis of the US Food and Drug Administration’s approval of the drug last year.
In the phase 3 trial of 472 patients, at a median follow-up of 41.2 months, the median overall survival for patients who received oral azacitidine was 24.7 months vs 14.8 months for those who received placebo (P < .0009; hazard ratio, 0.69).
“It’s not too hard to get these patients into remission,” Harry Erba, MD, PhD, Duke Cancer Institute, Durham, North Carolina, told Medscape Medical News in 2019. “The problem comes in keeping them in remission.”
The most common adverse effects are nausea, vomiting, diarrhea, neutropenia, and thrombocytopenia, according to the EMA.
The new drug represents a first in the treatment of this patient group.
“Despite various attempts, there has been no success over the past 30 years in defining maintenance treatment for these patients, Andrew Wei, MBBS, PhD, from the Alfred Hospital in Melbourne, Australia, said in 2019.
“Oral azacitidine represents a new therapeutic standard for patients with AML in remission,” he commented.
Nick Mulcahy is an award-winning senior journalist for Medscape, focussing on oncology, and can be reached at [email protected] and on Twitter @MulcahyNick.
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