Decitabine launched for acute myeloid leukaemia
Decitabine has been launched for the treatment of acute myeloid leukaemia in the over 65s. It will be marketed as Dacogen by Janssen-Cilag.
The European Commission granted decitabine a licence as it has been shown to lead to a small, but relevant, improvement in survival time for the target patient group.
Decitabine is a cytidine deoxyneucleoside analogue that inhibits DNA methyltransferases. This stops the cancer cells from dividing and so eventually leads to cell death.
The dose of decitabine is 20mg/m2 body surface area, calculated using the patient’s height and weight. This is administered by intravenous infusion over an hour and repeated for five days in a row. This five day course constitutes one treatment cycle, to be repeated every four weeks. A minimum of four cycles is recommended, at which point response and toxicity should be evaluated. However, treatment may be continued for as long as the patient continues to show benefit.
Decitabine was trialled in an open-label, randomised, multicentre phase III study (n=485), in patients with newly diagnosed primary de novo, or secondary, acute myeloid lymphoma (according to World Health Organization classification), 64 years of age or over, for whom standard induction chemotherapy was not appropriate. Decitabine increased mean survival to 7.7 months compared with 5.0 months for patients given supportive care alone or 20 mg/m2 cytarabine subcutaneously once daily for 10 consecutive days repeated every four weeks.
The most serious common side effects from treatment with decitabine were pneumonia, thrombocytopenia, neutropenia, febrile neutropenia and anaemia. Discontinuation due to adverse events was noted to be more common in women than men treated with decitabine.
Class: Antineoplastic agent.
Dose: 20mg/m2 body surface area by intravenous infusion over an hour and repeated for five days, not to exceed 100mg/m2 in that five-day period. The treatment cycle should be repeated every four weeks. A minimum of four cycles is recommended.
NHS list price: 5mg/ml powder for solution for infusion, 1 x 10ml pack (50mg), £970.86.
Legal category: POM.
Citation: The Pharmaceutical Journal URI: 11112002
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