Users of the Drug Registries subject to Monitoring are informed that, following the publication of the AIFA Determination in the Official Gazette no. 1 of , starting from the end of the monitoring of the Registries for the following therapeutic indications:
is indicated in adult patients suffering from:
- chronic phase myeloid leukemia with Philadelphia chromosome positive (Ph CML), accelerated blast resistant or intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or in patients in whom the T315I mutation has been identified;
- acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph ALL) resistant to dasatinib; intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or in which the T315I mutation has been identified.
It is specified that the management of patients already in treatment with the medicinal product in question subjected to a monitoring register guarantees the continuation of treatment in the manner defined in the registry card, until the closure of treatment.
Finally, please note that the clinician can proceed with the compilation of the end of treatment form by selecting the item «Monitoring Closure» present among the causes of end of treatment.
The complete circular in PDF format is available at:
https://www.aifa.gov.it/documents/20142/_Iclusig.pdf
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Source — https://www.univadis.it/viewarticle/chiusura-dei-registri-di-monitoraggio-iclusig