The U.S. Food and Drug Administration has approved Taiho Oncology’s Inqovi (decitabine and cedazuridine) plus venetoclax for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy.
The combination of Inqovi plus venetoclax is the first and only oral hypomethylating regimen approved for this population, offering an alternative to parenteral hypomethylating agent-based regimens that require frequent clinic visits.
The approval was based on results from the Phase II ASCERTAIN-V study, which showed that the combination treatment resulted in 42 patients achieving a complete remission (CR; 41.6%), with a median time to CR of two months. The median duration of CR was not reached.
Serious adverse reactions occurred in 82% of patients who received the combination treatment, including serious adverse reactions of febrile neutropenia (31%), sepsis (22%), pneumonia (15%), bacterial or viral infection (10%), hemorrhage (9%), and dyspnea (6%). Fatal adverse reactions occurred in 8% of patients.
“This approval marks an important step forward in expanding how treatment can be delivered for this patient population, offering an all?oral option that can potentially reduce the overall treatment burden associated with receiving treatment in hospitals or infusion centers,” Harold Keer, M.D., Ph.D., the chief medical officer at Taiho Oncology, said in a statement.
“We believe this approach has the potential to make a meaningful impact for patients and caregivers.”
More information
Key medical concepts
Clinical categories
The content is provided for information purposes only.