U.S. FDA Approves INQOVI® Plus Venetoclax for Acute Myeloid Leukaemia
Thursday, May 14, 2026
Taiho Oncology and Taiho Pharmaceutical have received approval from the U.S. Food and Drug Administration for INQOVI® (decitabine and cedazuridine) in combination with venetoclax for the treatment of adults with newly diagnosed acute myeloid leukaemia (AML) who are aged 75 years or older or are not suitable for intensive induction chemotherapy.
The approval makes INQOVI plus venetoclax the first fully oral combination treatment approved for this group of AML patients. The treatment provides an alternative to injectable hypomethylating agent-based therapies that often require regular hospital or clinic visits.
The decision was supported by findings from the Phase 2 ASCERTAIN-V study involving adults with newly diagnosed AML who were not eligible for intensive induction chemotherapy.
Study results showed that 42 patients achieved complete remission, representing a response rate of 41.6%. The median time to complete remission was two months, while the median duration of remission had not yet been reached during the study period.
The prescribing information for the therapy includes warnings related to myelosuppression and embryo-fetal toxicity.
INQOVI is already approved in the United States and Canada for treating adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukaemia (CMML).
Acute myeloid leukaemia is a cancer affecting the blood and bone marrow. In 2026, around 22,720 people in the United States are expected to be diagnosed with AML. More than half of these patients may not be eligible for intensive induction chemotherapy because of age or other health conditions.
The companies stated that the approval expands access to oral anti-cancer treatment options and may help reduce the treatment burden associated with hospital- or infusion-based therapies for patients and caregivers.
Source: businesswire.com
