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AUG 25 2026
UPCOMING · 83 DAYS TO PDUFA

Xspray Pharma AB Dasynoc (dasatinib)

for chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL)

NDA

Accepted FEB 26 2026.

About

Chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL) are blood cancers where abnormal white blood cells multiply uncontrollably. Dasynoc (dasatinib) blocks signals that drive cancer cell growth by targeting specific proteins involved in cell division. This approach may help slow disease progression by interfering with the mechanisms that allow leukemia cells to thrive.

Pivotal trial

CCCG-TALL-2025 Phase 2/Phase 3 recruiting NCT06855810

This is a prospective, multicenter study conducted within the Chinese Children's Cancer Group (CCCG). The study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (MRD)-negative remission rate, enhance event-free survival (EFS), and reduce the cumulative incidence of relapse (CIR) in pediatric patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).

Source: ClinicalTrials.gov

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