Shots:
- The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026)
- sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts received Inqovi on days one through five & venetoclax daily in each 28-day cycle, with a mFU of 11.2mos.
- Trial met its 1EP with a CR rate of 46.5% (n=47), while 2EPs showed a CR + CR with incomplete hematologic recovery rate of 63.4% (n=64), mOS of 15.5mos., unreached mDoR, with >75% pts who achieved CR maintaining response at 12mos.; data was shared at ASCO & EHA 2025
Ref: Prnewswire | Image: Taiho| Press Release
Related News:- Alexion Partners with JCR Pharmaceuticals to Develop Genomic Medicines
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
