The FDA has granted Taiho Pharmaceutical and its U.S. subsidiary, Taiho Oncology approval for Inqovi (decitabine and cedazuridine) in combination with venetoclax, making this the first all-oral regimen for acute myeloid leukemia (AML).
In the phase 3 ASCERTAIN-V trial, the regimen met its complete remission (CR) and duration of CR (DoCR) endpoints, showing a median time to CR of two months.
Inqovi is already approved for myelodysplastic syndromes and chronic myelomonocytic leukemia. The phase 3 trial with venetoclax revealed no new safety concerns.
The treatment will be available to newly-diagnosed patients who are ineligible to receive intensive induction chemotherapy or who are aged 75 years or above. It will provide an alternative to parental hypomethylating agents.