Early in July, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product decitabine (Dacogen®), Janssen-Cilag), 50 mg, powder for concentrate for solution for infusion, intended for the treatment of acute myeloid leukemia (AML).
Decitabine, a pyrimidine analogue (L01BC08)is a cytosine nucleoside analogue which inhibits DNA methyltransferase. In the treatment of AML, decitabine shows an increase in overall survival. The most common side effects are pyrexia, pneumonia, thrombocytopenia, anemia, febrile neutropenia, neutropenia, nausea and diarrhea.
The CHMP approved decitabine for the "... treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to the World Health Organization (WHO) classification, who are not candidates for standard induction chemotherapy”. Decitabine should be prescribed by physicians experienced in the use of chemotherapeutic agents.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission. The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favorable benefit-to-risk balance for decitabine and therefore recommends the granting of the marketing authorization.
For more information:
- Orphan drug designation
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