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# Takeda Reports Cancer Drug’s Disappointing Trial Data
- URL: https://www.fdaweb.com/takeda-reports-cancer-drugs-disappointing-trial-data/
- Published: 2021-09-02T12:00:00.000Z
- Updated: 2026-09-14T17:12:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150073

Takeda Pharmaceutical is reporting disappointing data from its Phase 3 PANTHER (Pevonedistat-3001) study, which did not achieve pre-defined statistical significance for the primary endpoint of event-free survival (EFS). The trial evaluated whether the combination of pevonedistat plus azacitidine as first-line treatment for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and low-blast acute myeloid leukemia (AML) improved EFS versus azacitidine alone. An event in the trial was defined as death or transformation to AML in participants with higher-risk MDS or CMML, whichever occurs first, and death in participants with AML, according to the company. Full data results will be presented at an upcoming medical congress, it says. Pevonedistat is described as an NEDD8-activating enzyme (NAE) inhibitor that targets cancer cell death by disrupting protein homeostasis.