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The data

Vyxeos Liposomal is the first chemotherapy to significantly increase overall survival (OS) vs conventional chemotherapy** in patients with high-risk* acute myeloid leukaemia (AML)1

the data
Vyxeos Liposomal Data Presentation
Reinforcing Clinical Results in the Real-World

German Real-World Evidence
Clinical Summary

SmPC and Prescribing Information are available in the menu
Laying the Foundation Towards Long-Term Survival

Italian Real-World Evidence
Clinical Summary

SmPC and Prescribing Information are available in the menu

Phase 3 Study

SmPC and Prescribing Information are available in the menu

For more publications, educational videos and downloadable materials – Click here
Vyxeos Liposomal: a breakthrough in
chemotherapy for high-risk* AML1,2
Survival estimated from KM curves
Better
overall survival vs conventional chemotherapy**

Primary endpoint: Median OS1

9.6 months
6.0 months
(HR: 0.69, 95% CI: 0.52-0.90, p=0.005 [2-sided]3)
See the Phase III paper
Greater
long-term
survival vs conventional chemotherapy**
1
1-year survival1
42%
28%
2
2-year survival1
31%
12%
5
5-year survival4
18%
8%
Post-hoc analysis
Post-transplant
survival4†

Overall survival was maintained above 50% at 5 years post-randomisation in patients who received Vyxeos Liposomal 4

Vyxeos Liposomal Conventional chemotherapy **

See the 5-year follow-up paper

Comparable safety profile1vs conventional chemotherapy**

Vyxeos Liposomal provides improved efficacy vs conventional chemotherapy** without increasing the toxicity burden1

Vyxeos Liposomal patients may require additional monitoring for prolonged thrombocytopenias​ and neutropaenias, due to the persistent activity in the bone marrow1,3

Please refer to the SmPC for the full information about the safety and tolerability of Vyxeos Liposomal3
Additionally, for information on the full range of adverse events in the Phase III clinical paper - click here

  • * High-risk AML is defined as therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
  • ** Comparator arm conventional chemotherapy is 7+3 in induction, 5+2 in second induction and consolidation where given
  • † Estimated from the date of randomisation as follow-up time from the date of HSCT was less than 5 years
This website is intended for European Healthcare Professionals only.
REFERENCES
  • Lancet JE et al. J Clin Oncol 2018;36(26):2684-92.
  • U.S. Food and drug administration 2017. FDA news release: FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia.
  • Vyxeos Liposomal. European Summary of Product Characteristics.
  • Lancet JE et al. Haematol 2021;8(7):e481-91.

ADVERSE EVENTS REPORTING

Adverse events should be reported. Healthcare professionals are asked to report any adverse events via their national reporting system (see Section 4.8 of SmPC). Adverse events should also be reported to Jazz Pharmaceuticals by email to medinfo-int@jazzpharma.com or phone via +353 1 968 1631 (may include an international call charge).

Job code: INT-VYX-2200141
Date of Preparation: May 2023
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If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly through your national medicines side effect reporting system or to Jazz Pharmaceuticals AEreporting@jazzpharma.com. By reporting side effects, you can help provide more information on the safety of this medicine.