Duration of Treatment
Continued treatment with VIDAZA® can increase response quality in responders.1
91% of first responses to VIDAZA® occurred by 6 cycles1
Some MDSa patients respond rapidly to VIDAZA®, and continued VIDAZA® therapy results in a qualitative increase in response quality in almost half of the responders.1
- In the remaining 9% of patients with stable disease at 6 cycles, continued therapy resulted in achievement of a first response.1
- Although the majority of first responses occurred by 6 cycles, continued treatment with VIDAZA® led to improved response quality in 48% of all responders with a median of 3 additional cycles.
- Best response was achieved by 92% of responders by 12 cycles.1
Treatment with VIDAZA® should be continued as long as the patient continues to benefit or until disease progression to achieve a survival benefit for patients achieving complete response, partial response or haematological improvement.1
Why is duration of treatment important?
- VIDAZA® is believed to work by hypomethylation of DNA and re-expression of silenced genes regulating normal cell cycle differentiation, as well as by direct cytotoxicity2
- Incorporation of VIDAZA® into DNA is S-phase dependent and requires exposure during multiple cycles of DNA replication for maximal demethylation1,3
- Two or more cell cycles with subsequent DNA synthesis appear necessary to reinitiate gene transcription and expression4
- When VIDAZA® is discontinued, aberrant promoter methylation and gene silencing return1
- Survival benefit with VIDAZA® occurs in patients achieving CR, PR and HI, despite the persistence of cytogenetic abnormalities. It is therefore important to maintain treatment until progression.4
- Silverman LT et al.Cancer. 2011. 117:2697-2702.
- VIDAZA® Summary of Product Characteristics, 2011.
- Santini V et al. Ann Intern Med 2001.134: 573-86.
- Fenaux P et al. Leuk Res 2010; 34(11): 1410-6.
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.
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.