Journal of Clinical Oncology publishes pivotal Phase 3 data for Jazz Pharmaceuticals' Vyxeos® (daunorubicin and cytarabine) Liposome for Injection
Jazz Pharmaceuticals plc - Ordinary Shares (JAZZ)
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Source: PR Newswire
DUBLIN, July 19, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that data from the pivotal Phase 3 study of Vyxeos® (daunorubicin and cytarabine) liposome for injection compared to standard of care cytarabine and daunorubicin (7+3) were published online in the Journal of Clinical Oncology. The study evaluated the efficacy and safety of Vyxeos compared to 7+3 in 309 patients who were between 60 to 75 years of age with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), a rapidly progressing and life-threatening blood cancer. The study met its primary endpoint as Vyxeos demonstrated a superior improvement in overall survival compared to the 7+3 treatment regimen. The median overall survival for the Vyxeos treatment group was 9.6 months compared with 5.9 months for the 7+3 treatment group (2-sided p value = 0.005; HR [95% confidence interval] = 0.69 [0.52, 0.90]). Vyxeos was also associated wit
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