Dacogen: new option for acute myeloid leukaemia

Dacogen (decitabine) has been launched for the treatment of acute myeloid leukaemia (AML) in patients aged 65 years or above who are unsuitable for standard induction chemotherapy.

Dacogen is licensed for the treatment of AML in adults aged 65 years or above.
Dacogen is licensed for the treatment of AML in adults aged 65 years or above.

PHARMACOLOGY

Decitabine is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases, resulting in reactivation of tumour suppressor genes, induction of cellular differentiation and activation of programmed cell death.1

CLINICAL STUDIES

Decitabine displayed efficacy in an open-label multicentre phase III study (DACO-016) in 485 patients aged ≥65 years with AML. Patients were randomised 1:1 to receive decitabine 20mg/m2 by intravenous infusion once daily for 5 days every 4 weeks or treatment choice (supportive care or cytarabine 20mg/m2 by subcutaneous injection once daily for 10 days every 4 weeks). The primary endpoint was overall survival.2

Higher response rate than control arm

Median overall survival in the intention-to-treat analysis was 7.7 months in the decitabine arm compared with 5 months in the treatment choice arm; this difference was not significant (HR 0.85, 95% CI 0.69–1.04; p=0.108). However, decitabine was associated with a significantly higher response rate than treatment choice (17.8% vs 7.8%; p=0.001).2

Safety profile comparable to cytarabine

Similar rates of adverse events were observed with decitabine and cytarabine. The most common adverse events seen with decitabine were thrombocytopenia and neutropenia.2

References:

  1. Dacogen Summary of Product Characteristics, September 2012.
  2. Kantarjian HM et al. J Clin Oncol 2012; 30: 2670–7.

View Dacogen drug record

Further information: Janssen-Cilag Ltd

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