PRINCETON, N.J. — Taiho Oncology and Taiho Pharmaceutical said the U.S. Food and Drug Administration has approved INQOVI in combination with venetoclax for adults with newly diagnosed acute myeloid leukemia who are 75 or older or are ineligible for intensive induction chemotherapy.
The companies said the approval makes INQOVI, which combines decitabine and cedazuridine, the first all-oral combination regimen approved for that patient population. The treatment offers an alternative to parenteral hypomethylating agent-based regimens that require frequent clinic visits.
The FDA approval was based on results from the Phase 2 ASCERTAIN-V clinical trial evaluating INQOVI plus venetoclax in adults with newly diagnosed AML who were ineligible for intensive induction chemotherapy.
Taiho said efficacy was established based on complete remission and duration of complete remission. In the trial, 42 patients achieved a complete remission, representing 41.6% of participants, with a median time to complete remission of two months. The median duration of complete remission was not reached.
The prescribing information includes warnings and precautions for myelosuppression and embryo-fetal toxicity, the companies said.
“This FDA approval represents a significant milestone for patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive induction chemotherapy,” said Peter Melnyk, President and Chief Executive Officer of Taiho Oncology. “With the approval of an all-oral regimen, INQOVI in combination with venetoclax brings a new treatment option to this patient population and underscores our commitment to advancing innovative, patient-focused therapies in hematologic malignancies.”
INQOVI was previously approved in the U.S. and Canada for adults with myelodysplastic syndromes and chronic myelomonocytic leukemia.
Taiho said an estimated 22,720 people in the U.S. are expected to be diagnosed with AML in 2026. More than half are likely to be ineligible for intensive induction chemotherapy because of age or health concerns, according to the company.
“As a leader in the development of oral anti-cancer regimens, we are proud that INQOVI in combination with venetoclax will now be available for newly diagnosed patients with acute myeloid leukemia in the U.S.,” said Harold Keer, MD, PhD, Chief Medical Officer of Taiho Oncology. “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. We believe this approach has the potential to make a meaningful impact for patients and caregivers.”
