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Current treatment options |
EMA: Treatment for AML is complex and depends on a number of factors including the extent of the disease, whether it has been treated before, and the patient’s age, symptoms and general state of health. At the time of designation, the main treatments for AML were chemotherapy (medicines to treat cancer) and haematopoietic (blood) stem-cell transplantation (a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow). |
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Therapeutic value |
Possible added value
This assessment does not indicate any potential inclusion in the package. |
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Substantiation |
EMA: he sponsor has provided sufficient information to show that venetoclax might be of significant benefit for patients with AML because early studies show that, when used in combination with other medicines, it can produce a response in the disease in patients older than 65 years who cannot receive standard treatment. This assumption will need to be confirmed at the time of marketing authorisation, in order to maintain the orphan status. |
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Duration of treatment |
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Frequency of administration |
1 times a day |
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Dosage per administration |
600 mg |
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References |
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