News
Health Canada approves Vyxeos, the first chemotherapy advance in over 40 years for adults with high-risk acute myeloid leukemia .- Jazz Pharmaceuticals
Jazz Pharmaceuticals plc has announced the Health Canada approval and availability of Vyxeos (daunorubicin and cytarabine liposome for injection) for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
The approval of Vyxeos is based on results from a Phase III study of 309 adult patients, aged 60-75, with newly diagnosed t-AML or AML-MRC. The study met its primary endpoint as Vyxeos demonstrated a superior improvement in overall survival compared to the current conventional treatment group. The median overall survival for the Vyxeos treatment group was 9.6 months compared with 6.0 months for the current conventional treatment group.
Considered a rare disease, AML affects approximately 1,100 men and women in Canada annually. Though the number of AML cases has continued to rise, the current treatment regimen for patients with high-risk AML has remained the same for decades until now.
Condition: Acute Myelogeous Leukemia (AML)
Type: drug