Vyxeos® Liposomal – indicated populations

Vyxeos® Liposomal: Who?

Vyxeos Liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)2

  • The World Health Organisation (WHO) define specific AML disease entities by focusing on significant cytogenetic and molecular genetic subgroups3
  • t-AML and AML-MRC are distinct subcategories with high-risk features5
  • Up to a third of AML patients may fall into these high-risk categories6,7
*US FDA Breakthrough Therapy designation granted for Vyxeos Liposomal for the treatment of t-AML or AML-MRC1
**High-risk AML is defined as therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)

References

  1. US Food and Drug Administration. FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia. 2017. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-certain-types-poor-prognosis-acute-myeloid-leukemia. Accessed November 2019
  2. Vyxeos Liposomal – Summary of Product Characteristics, October 2019
  3. Arber DA et alBlood 2016; 127(20): 2391-2405
  4. Weinburg OK et al. Blood 2009; 113(9): 1906-1908
  5. Boddu PC et al. Cancer 2017; 123(16): 3050-3060
  6. Granfeldt Ostgard LS et al. J Clin Oncol 2015; 33(31) 3641-3649
  7. Nagel G et al. Ann Hämatom 2017; 96(12) 1993-2003

 

ADVERSE EVENTS REPORTING

 

Reporting of side effects: Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via their national reporting system. Adverse events should also be reported to Jazz Pharmaceuticals by email: AEreporting@jazzpharma.com or by fax to +44 (0) 1865 598765

 

INT-VYX-1900008 | January 2020