Vidaza

Oncology· 127 cited findings· 1 source document

What the regulatory reviews say

Vidaza (azacitidine) is indicated for the treatment of Myelodysplastic Syndromes (MDS), a condition with a calculated prevalence of 1.1 to 3 in 10,000 persons. The drug received Orphan medicinal product designation on 06 February 2002, with various Marketing Authorisation dates, including 27.01.2006 and 25.03.2007, and European Commission Decisions adoption on 17 December 2008.

In a clinical study (AZA-001) involving 179 patients in the azacitidine arm and 179 in the conventional care regimens (CCR) arm, Vidaza demonstrated a median overall survival of 24.46 months. This compared to a median overall survival of 15.02 months for CCR, resulting in a difference of 9.4 months (p-value for overall survival: 0.0001; hazard ratio for treatment effect: 0.58). Actuarial survival at 4 years was 26% for Vidaza, compared to 10% for non-intensive treatment or supportive care.

Regarding safety, 100.0% of patients receiving azacitidine experienced at least one treatment-emergent adverse event (TEAE). On-treatment deaths were 12.0% for azacitidine, compared to 18.6% for best supportive care (BSC only). A total of 449 patients were exposed to azacitidine in completed clinical MDS studies, with an estimated 27,591 patients having azacitidine experience overall. Treatment discontinuation due to toxicity occurred in 22 patients.

Key figures — cited to the source page

median overall survival (azacitidine)	24.46	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.51
median overall survival (CCR)	15.02	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.51
difference in median overall survival	9.4	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.51
p-value for overall survival	0.0001	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.51
hazard ratio for treatment effect	0.58	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.51
on-treatment deaths (azacitidine)	12.0	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.42
on-treatment deaths (BSC only)	18.6	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.42
Marketing Authorisation date	27.01.2006	Bristol-Myers Squibb Company — Vidaza EMA EPAR public assess, p.3

Source documents

Bristol-Myers Squibb Company — Vidaza EMA EPAR public assessment report (EMEA/H/C/000978, 2008) (2008)

Explore the full evidence

All 127 cited findings for Vidaza — searchable, comparable and answerable in plain language — are in the Oncology research library →

Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.