Canada Approves Jazz's Vyxeos To Treat High-risk Acute Myeloid Leukemia

Jazz Pharmaceuticals plc (JAZZ) said that the Health Canada has approved 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 or AML-MRC.

The approval was based on results from a Phase 3 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.

The most common adverse reactions attributed to Vyxeos are infection, febrile neutropenia, rash, transfusion reactions, sleep disorders, anxiety, delirium, headache, dizziness, visual impairment, non-conduction cardiotoxicity, arrhythmia, chest pain, hemorrhage, hypotension, hypertension, dyspnea, cough, and others.

AML, a cancer of the bone marrow and the blood, progresses rapidly without treatment. Specifically, high-risk AML includes t-AML and AML-MRC. T-AML is caused by previous therapeutic treatments while AML-MRC occurs when there are certain changes in the bone marrow, which is the spongy tissue inside the bones.

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