Onureg is now available in general hospitals

a new acute myeloid leukemia (AML) treatment

Onureg can be prescribed in Big 5 tertiary general hospitals and 40 other hospitals in Korea

Onureg received approval in 2022 and became eligible for reimbursement starting from August 2023

BMS Pharmaceutical Korea’s Onureg (azacitidine), a new drug for treating acute myeloid leukemia (AML).

General hospitals can now prescribe ‘Onureg,’ an oral acute myeloid leukemia drug.

 

According to industry sources, BMS Pharmaceutical Korea’s Onureg (azacitidine), a new drug for treating acute myeloid leukemia (AML), has recently passed the Drug Committee (DC) of Big 5 tertiary general hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Seoul St.

 

Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital, as well as 40 hospitals across the country.

 

Onureg received approval in Korea in March 2022 and passed the Health Insurance Review and Assessment Service's (HIRA) Cancer Drug Review Committee in December of the same year.

 

Subsequently, Onureg has been included in the insurance reimbursement listing since August after passing the HIRA’s Drug Reimbursement Committee.

 

Reimbursement for Onureg is provided if all the following criteria are met: ▲Cytogenetically defined as being at severe to high risk, ▲Has no history of using a hypomethylating agent (HMA), ▲Having no history of stem cell transplantation, ▲55 or older, and patient’s general state is not suitable for stem cell transplantation, ▲Administered within 7 days before and after 4 months of achieving complete remission (first CR or Cri) after receiving induction chemotherapy.

 

The effectiveness of Onureg was demonstriated in Phase 3 QUAZAR AML-001 clinical study, which enrolled 472 patients with AML.

 

Based on clinical results, patients who received Onureg had a median overall survival (mOS) of 24.7 months, an extension of 10-month compared to the 14.8 months observed in those treated with control.

 

This improvement represented a 31% reduction in mortality risk.

 

The rate of surviving patients in the Onureg-treated group at year one post-treatment was 73% (place group: 56%), and at year two post-treatment was 51% (place group: 37%).

 

Onureg demonstrated higher survival rates than the placebo group in both periods.

 

Onureg treatment prolonged relapse-free survival (RFS) by 5.3 months in patients to 10.2 months, thus demonstrating its effect in reducing the risk of relapse.

 

"For patients with AML who have achieved remission following standard-dose induction chemotherapy but are not eligible for stem cell transplantation, receiving secondary treatments, aiming to prolong the state of complete remission (CL) and minimize the risk of relapse as possible, is critical.

 

The reimbursement of Onureg is good news for patients with AML who were previously unable to receive maintenance therapy due to limited treatment options," Cheong, June-Won, a Professor in the Division of Hematology at the Department of Internal Medicine at Severance Hospital, stated.