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AUG 25 2026
UPCOMING · 25 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 is a cancer of the blood and bone marrow that affects myeloid tissue. Dasynoc (dasatinib) is a tyrosine kinase inhibitor that blocks specific proteins that signal cancer cells to grow and divide. By interfering with these growth signals, the drug may help control the progression of the disease.

Pivotal trial

NCT04530565 Phase 3 active not recruiting NCT04530565

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread

Source: ClinicalTrials.gov

Also in development