BMS Pharmaceutical Korea said on Tuesday that it released acute myeloid leukemia (AML) maintenance therapy Onureg (ingredient: azacitidine) in Korea on Monday.

In March 2022, Onureg won domestic approval to treat AML patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy regardless of the presence or absence of hyperplasia therapy. 

It is for adults with AML in which hematopoietic stem cell transplantation (HSCT) is not suitable.

AML is fast-growing cancer whereby myeloblasts rapidly multiply in the bone marrow and blood but can spread to other regions if not quickly treated. Patients with AML can expect complete remission through HSCT, but about 50 to 75 percent of patients do not use this treatment due to old age, comorbidities, and toxicity in previous treatments.

Patients unsuitable for HSCT are at high risk of recurrence because there is no effective treatment to maintain remission.

"AML is aggressive and fatal, so even if complete remission occurs, about half of the patients will experience recurrence within one year," said Professor Kim Hee-je, Director of Haematology at the Catholic University of Korea Seoul St. Mary's Hospital. “Therefore, expectations are high for Onureg, which has shown a median increase in the overall survival of about 10 months through oral maintenance therapy.”

Onureg is the first approved oral maintenance AML therapy in Korea with proven clinical effects. It is administered orally once daily. The drug achieved a median overall survival (mOS) of 24.7 months, 10 months longer than the placebo group (14.8 months) in patients with AML who were not eligible for HSCT after achieving CR or CRi in the QUAZAR AML-001 clinical trial. Additionally, it demonstrated a median recurrence-free survival (RFS) of 10.2 months compared to the placebo group (4.8 months), confirming a reduced risk of recurrence.

"We have been trying to introduce new drugs for rare blood cancer patients in Korea, starting with the permission for Reblozyl (ingredient: luspatercept) last year, followed by Inrebic (ingredient: fedratinib) and Onureg," BMS Pharmaceutical Korea CEO Lee He-young said, “We will continue to do our best to improve the treatment environment and patient access for not only AML but other serious diseases."

The company also aims to get a health insurance benefit for the drug.