VIDAZA® Treatment for AMLb

About VIDAZA®

VIDAZA®: Changing the treatment of acute myeloid leukaemia (AMLb).

Treatment Indication

VIDAZA® is indicated for the treatment of adult patients with acute myeloid leukaemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification, who are not eligible for haematopoietic stem cell transplantation.1

Optimising outcomes in AMLb

Desired treatment outcomes in patients over 65 years old with AML:

  • Improved overall survival
  • Improved quality of life
    • Greater transfusion-independence
    • Fewer fevers requiring IV anitibiotics
    • Less frequent hospitalization
    • Less fatigue

Adult AML: A fatal haematological malignancy with limited treatment options and poor survival outcomes

Survival in patients <65 vs 65+ years in AML & 5-year relative survival rates at diagnosis in AML

  • AML accounts for around 80% of all adult acute leukaemias (median age at diagnosis: ~67 years)2,3
  • Outcomes depend on several factors: patient age, comorbidities, karyotype, mutational status, blast count2-4
  • In AML, younger patients (aged <65 years) have better outcomes – due to various factors including comorbidities and general overall fitness3,5
  • Due to comorbidities, few elderly patients are appropriate candidates for transplantation6
    • e.g., the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score in 177 patients with AML (median age 70 years) was 0 in 22%, 1-2 in 30%, and ≥3 in 48%, reflecting worse outcomes with higher HCT-CI scores6

VIDAZA® significantly extends overall survival compared with CCR in patients with WHO-defined AMLb (20-30% blasts)7

Subgroup analysis of a phase III, international, multicentre, randomised, controlled, parallel-group trial.7,8

Overall survival: VIDAZA® vs. CCR7

Overall Survival

VIDAZA® treatment is associated with improved median OS vs CCR; 24.5 vs 16 months (HR=0.47; 95% CI 0.28 to 0.79, p=0.005)7

†In the overall adult AML population.

‡Conventional care regimens: Best supportive care only (BSC); low-dose ara-C (LDAC); intensive chemotherapy (IC) In patients with WHO-defined AML (20-30% blasts)

  1. VIDAZA® Summary of Product Characteristics, 2011.
  2. Laubach J, Rao AV. Oncologist 2008;13:1097-1108.
  3. Klepin HD, Balducci L. Oncologist 2009;14:222-232.
  4. NCCN Clinical Practice Guidelines in Oncology. AML V.2.2010. Available from URL:http://www.nccn.org/professionals/physician_gls/pdf/aml.pdf.
  5. Surveillance Epidemiology and End Results. National Cancer Institute. Table 13.15 Myeloid Leukemia. Data 1999-2005. Available from URL:http://www.seer.cancer.gov/csr/1975_2006/browse_csr.php?section=13&page=sect_13_table.13.html.
  6. Giles FJ et al. Br J Haematol 2007;136:624-627.
  7. Fenaux P et al. J Clin Oncol 2010;28:562-569.
  8. Fenaux P et al. Lancet Oncol 2009;10:223-232.
a. MDS-specific Indication

VIDAZA® is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:

  • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
  • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder
b. AML-specific Indication:

Treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20-30% blasts and multi-lineage dysplasia, according to the WHO classification. WHO classifies RAEB-T patients with blasts ≥20% to <30% as AML patients.

Disclaimer

This is an international website for VIDAZA® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

The information on this website is based on the European Summary of Product Characteristics (SmPC). Please refer to your country-specific website, or contact a Celgene representative in your country for the latest information specific to your country.