VIDAZA® Treatment for AMLb

Efficacy

VIDAZA® is the first drug treatment to significantly prolong overall survival versus CCR in AMLb.1

VIDAZA® improves survival in AMLb patients1

  • Of 113 patients meeting the WHO AML definition (median: 23% blasts), 55 were randomised to receive VIDAZA® and 58 to receive CCR
  • VIDAZA® shows a survival benefit over CCR

2-years OS with VIDAZA® (AZACITIDINE) in AML patients

Median OS was 24.5 months with VIDAZA® vs. 16 months with CCR (p=0.004)1

†Conventional care regimens (Best supportive care [BSC] only, included in each arm, n=105; Low dose Ara-C [LDAC, 20 mg/m2/d x 14d q28d], n=49; Intensive chemo [Ara-C, 100-200 mg/m2/d by continuous IV infusion x 7d+3d IV daunorubicin 45-60 mg/m2/d, idarubicin 9-12 mg/m2/d, or mitoxantrone 8-12 mg/m2/d], n=25)3

  1. Fenaux P et al. J Clin Oncol 2010;28:562-569.
  2. Vardiman JW et al. Blood 2002; 100: 2292-2302.
  3. Fenaux P et al. Lancet Oncol 2009;10:223-232.
2 year survival rate

  • VIDAZA® tripled 2-year overall survival rates vs CCR in patients with WHO-defined AMLb (20-30% blasts)1
    • 50% for VIDAZA® vs. 16% CCR*; p=0.0007
  • The morphologic complete remission (CR) rate was 18% (10/55 patients) with VIDAZA® vs 16% (9/58 patients) with CCR group (p=0.80)1

These findings suggest that VIDAZA® can prolong survival in the absence of CR1

*Conventional care regimens (Best supportive care [BSC] only, included in each arm, n=105; Low dose Ara-C [LDAC, 20 mg/m2/d x 14d q28d], n=49; Intensive chemo [Ara-C, 100-200 mg/m2/d by continuous IV infusion x 7d+3d IV daunorubicin 45-60 mg/m2/d, idarubicin 9-12 mg/m2/d, or mitoxantrone 8-12 mg/m2/d], n=25)

  1. Fenaux P et al. J Clin Oncol 2010;28:562-569.
Percent of transfusion in independent patients

  • Proven survival benefits
  • Transfusion independence

Of the VIDAZA® patients who were RBC transfusion-dependent at baseline, 41% became RBC transfusion-independent during the treatment period compared to 18% with CCR* (p=0.04).1

*Conventional care regimens (Best supportive care [BSC] only, included in each arm, n=105; Low dose Ara-C [LDAC, 20 mg/m2/d x 14d q28d], n=49; Intensive chemo [Ara-C, 100-200 mg/m2/d by continuous IV infusion x 7d+3d IV daunorubicin 45-60 mg/m2/d, idarubicin 9-12 mg/m2/d, or mitoxantrone 8-12 mg/m2/d], n=25)1

†Red Blood Cell (RBC) transfusion independence is defined as the absence of RBC transfusions during 56 consecutive days

  1. Fenaux P et al. Lancet Oncology 2009. 10:223-232.
  2. Fenaux P et al. J Clin Oncol 2010. 28:562-569.
  1. Fenaux P et al. J Clin Oncol 2010;28:562-569.
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.