The domestic marketing authorization for BMS’s acute myeloid leukemia (AML) treatment, ‘Onureg tablet (azacytidine).’ Is imminent.

The safety and efficacy review for the marketing authorization of Onureg, which had received FDA approval in 2020, is now complete in Korea.

According to industry sources on the 16th, the Ministry of Food and Drug Safety has completed verification on the efficacy of Onureg that BMS Korea had submitted an application for.

With the safety and efficacy review complete, experts expect Onureg, the first oral azacytidine, to be released within the first half of this year.

The AML treatments currently approved in Korea are Celgene’