Clinical Data

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Study Design

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Patient and Disease Characteristics

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AML Subtypes

Indication

Vyxeos® 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).1

T-AML:

  • Previously untreated AML with a history of prior cytotoxic treatment2

AML-MRC:

  • AML arising from previous myelodysplastic syndromes (MDS) or an MDS/myeloproliferative neoplasm3
  • AML with a specific MDS-related cytogenic abnormality3
  • AML with multilineage dysplasia (in the absence of mutations of NPM1 or biallelic mutation of CEBPA)3
Study overview
The Phase 3 study was a randomised, open-label, active-controlled study of Vyxeos vs cytarabine and daunorubicin (7+3) in patients aged 60-75 years with newly-diagnosed t-AML or AML-MRC1,4
Patients were diagnosed with t-AML, de novo AML with MDS karyotype and AML with a history of MDS and chronic myelomonocytic leukaemia (CMML) with a performance score between 0 and 21,4
309 patients took part in the study: 153 were randomised to Vyxeos and 156 patients were randomised to the 7+3 arm1,4
There were similar patient characteristics across both treatment arms1,4
The primary endpoint of the study was overall survival. Efficacy was established on the basis of overall survival from the date of randomisation until death due to any cause1,4

References

  1. VYXEOS summary of product characteristics
  2. Arber DA et al. Blood 2016; 127(20):2391-405
  3. Weinberg OK et al. Blood 2009; 113(9): 1906-8
  4. Lancet JE et al. J Clin Oncol 2016; 34(15 Suppl.): 7000

 

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. In the United Kingdom, reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported by email: AEreporting@jazzpharma.com or by fax to +44 (0) 1865 598765

 

 

EURW-INTVYX-0020a(1) | September 2019