Inqovi + Venclexta PDUFA Date (Taiho Oncology)

Name: FDA PDUFA Decision: Inqovi + Venclexta
Start: 2026-02-25

FDA PDUFA decision date for Inqovi + Venclexta is February 25, 2026. Developed by Taiho Oncology. Indication: Acute myeloid leukemia (AML) — first all-oral combination. Current status: Verifying.

Indication

Acute myeloid leukemia (AML) — first all-oral combination

Notes

PDUFA date passed. Awaiting public FDA decision. Phase 2b ASCERTAIN-V: 46.5% CR, 63.4% CR+CRi.

Regulatory details

Company: Taiho Oncology
Therapeutic area: Oncology
Application type: sNDA
Review type: Standard
PDUFA date: 2026-02-25
Outcome: Pending