Introduction
AML
DISEASE, ACUTE MYELOID LEUKEMIA, REMISSION, AML
The standard treatment strategy for newly diagnosed acute myeloid leukemia (AML) is an intensive curative chemotherapy, and a combination of cytarabine (AraC) and anthracycline is recommended as remission induction therapy. However, many AML patients are ineligible for intensive therapy because of advanced age or co-morbidities (Venetoclax is an orally available, small-molecule selective B-cell leukemia/lymphoma-2 inhibitor (In November 2018, the US Food and Drug Administration granted accelerated approval for venetoclax in combination with AZA, decitabine or LDAC for the treatment of newly diagnosed AML in adults aged ≥75 years or who have co-morbidities that preclude the use of intensive induction chemotherapy. The expanded access study (EAS) framework (Japanese compassionate use program) was established in January 2016. This framework can provide preapproval access to unapproved or off-label drugs for patients under the following conditions: the target disease is serious and life-threatening with no effective therapy available; the drug, either unapproved or off-label, is under development in Japan and is in the final stage of development, that is, the pivotal trial (confirmatory trial for new drug application) has ended or patient enrollment in the trial has finished (