Oral Inqovi, venetoclax for acute myeloid leukemia to be reviewed
FDA expected to complete its assessment by Feb. 25, 2026
The U.S. Food and Drug Administration (FDA) has agreed to review an application for oral Inqovi (decitabine and cedazuridine) in combination with oral venetoclax for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive first-line chemotherapy.
Submitted as a supplemental new drug application (sNDA) by Taiho Oncology, a subsidiary of Taiho Pharmaceutical, the review should be completed by Feb. 25, 2026.
“If approved for patients with AML who are not eligible to undergo intensive induction chemotherapy, Inqovi in combination with venetoclax would offer the first all-oral alternative to current therapies,” Harold Keer, MD, PhD, chief medical officer at Taiho Oncology, said in a company press release.
More than half of those diagnosed with AML, a type of blood cancer, are ineligible for intensive first-line, or induction, chemotherapy.
A ‘complete response’ to treatment
Inqovi is approved in the U.S. for adults with myelodysplastic syndromes (MDS), a group of diseases wherein the bone marrow doesn’t produce enough healthy blood cells, and for chronic myelomonocytic leukemia (CMML), a rare form of blood cancer.
The application to approve Inqovi combined with venetoclax is supported by data from the Phase 2b ASCERTAIN-V (NCT04657081) study, which enrolled 101 adults with newly diagnosed AML who were ineligible for intensive induction chemotherapy. Across 28-day treatment cycles, its participants received Inqovi on days one through five and venetoclax daily. The median follow-up was 11.2 months, or nearly a year.
Among those who could be evaluated, about half (46.5%) achieved a complete response, or no signs of cancer, meeting the primary goal. In secondary measures, more than half (63.4%) achieved either a complete response plus a complete response with a partial blood response. The median overall survival was 15.5 months, according to Taiho. At 12 months, the median duration of response hadn’t been reached, and more than three-fourths (75%) of those achieving a complete response remained in one.
No new safety concerns were reported and no drug-drug interactions were observed between Inqovi and venetoclax. Nearly all the patients (98%) reported a serious adverse event, most commonly febrile neutropenia, that is, a fever and a low count of immune neutrophils, anemia (low red blood cell count), and low neutrophil count, called neutropenia.
At 30 and 60 days after the first dose of Inqovi, three deaths (3%) were attributed to adverse events, and 10 (9.9%) to disease progression.
Data from ASCERTAIN-V were recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2025 European Hematology Association (EHA) Congress.
“We have an unwavering dedication to developing innovative new cancer treatments and the FDA’s acceptance of our sNDA for Inqovi in combination with venetoclax highlights the need for novel approaches in AML,” Keer said.
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