VIDAZA® Treatment for MDSa

Efficacy

VIDAZA® is the first drug treatment to significantly prolong overall survival versus CCR and alter the natural history of higher-risk MDS.1

Consistent survival across different MDSa cytogenetic groups1

VIDAZA® improves survival, irrespective of cytogenetics or age1,2

Median Overall Survival

VIDAZA® improved survival over CCR in patients with monosomy

  • At 2 years, OS for high-risk MDS patients with del(7q) was 4-fold higher in the VIDAZA® group than in the CCR group: 33% vs. 8%, respectively (p=0.03)3

VIDAZA® showed similar survival efficacy across all age groups (<65 years, 65-75 years and >75 years)3

  • In patients ≥ 75 years of age, OS rates at 2 years were significantly higher with VIDAZA® vs. CCR; 55% vs 15% respectively (p=0.0003)4

Learn more about VIDAZA® in patients ages 75 and older.

*In adults patients only†For 5% of patients cytogenetic data unknown‡Conventional care regimens (Best supportive care [BSC] only, included in each arm, n=105, Low dose Ara-C [LDAC, 20mg,m2/d x 14d q28d] n=49; Intensive chemo [Ara-C, 100-299mg/n2/d by continuous IV infusion x 7d+3d IV daunorubicin 45-60mg/m3/d, idarubicin 9-12mg/m3/d, or mitoxantrone 8-12mg/m3/d] n=25)2

  1. Fenaux P. et al. Lancet Oncol 2009. 10: 223-232.
  2. VIDAZA® Summary of Product Characteristics, 2011.
  3. Mufti GJ et al. J Clin Oncol 2008. 26: Abstract 7033.
  4. Seymour JF et al. Blood 2008. 112: Abstract 3629.

VIDAZA® almost doubles the median time to AML progression or death in Int-2 and High-risk MDS patients compared to CCR.*1

Median time to AML progression

*Conventional care regimens (Best supportive care [BSC] only, included in each arm, n=105; Low dose Ara-C [LDAC, 20 mg/m2/dx 14d q28d], n=49; Intensive chemo [Ara-C, 100-200 mg/m2/d by continuous IV infusion x 7d+3d IV daunoribucin 45-60 mg/m2/d, idarubicin 9-12 mg/m2/d, or nitoxantrone 8-12mg/m2/d], n=25)2(AZA-001)

  1. VIDAZA® Summary of Product Characteristics, 2011.

Haematological improvement offers survival benefit1,2

A survival benefit was also demonstrated in patients that had not achieved complete remission (CR) or partial remission (PR) following VIDAZA® treatment1,2

2-year OS with Vidaza by best response

*IWG, International Work Group

  1. List AF. Azacitidine extends overall survival (OS) in higher-risk MDS without the necessity for complete remission. Oral presentation. ASCO 2008 annual meeting. Session: Leukemia, myelodysplasia and transplantation.
  2. VIDAZA® Summary of Product Characteristics, 2011.

VIDAZA® leads to a reduced need for RBC* transfusions.

Of the VIDAZA® patients who were RBC transfusion dependent at baseline, 45% became RBC transfusion independent* during the treatment period compared to 11.4% with CCR (p<0.0001)1

Percentage of transfusion independent patients

Median duration of RBC transfusion independence was 13 months with VIDAZA®1

*Red Blood Cells (RBC) transfusion independence is defined as the absence of RBC transfusions during 56 consecutive days1†Conventional care regimens (Best supportive care [BSC] only, included in each arm, n=105; Low dose Ara-C [LDAC, 20m/m2/d x 14d q28d], n=49; Intensive chemo [Ara-C, 100-200mg/m2/d by continuous IV infusiong x 7d+3d IV dauorubicin 45-60mg/m2/d, idarubicin 9-12mg/n2/d, or mitoxantrone 8-12mg/m2/d] n=25)1

  1. Fenaux P. et al. Lancet Oncol 2009. 10: 223-232.
  1. Fenaux P et al. Lancet Oncology 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.