The US Food and Drug Administration approved the oral combination of decitabine and cedazuridine (Inqovi) with venetoclax for adults with newly diagnosed acute myeloid leukemia. The oral combination, developed by Taiho Oncology, Inc., is used with venetoclax for patients who are at least 75 years old or have other medical conditions that prevent the use of intensive chemotherapy.
The FDA previously granted orphan drug Designation to decitabine and cedazuridine for this indication.
The combination’s efficacy and safety were evaluated in the ASTX727-07 study. About 42% of patients in a clinical trial reached complete remission while taking the treatment. Patients reached remission in a median time of two months, and the median duration of these responses was not reached during the study, according to an FDA announcement.
The FDA announcement also lists prescribing information.
