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Autorizzazione all’immissione in commercio senza designazione orfana - Europa
- denominazione commerciale: VENCLYXTO
- Codice ATC : L01XX52
- Numero EU: EU/1/16/1138
- AIC data : 07/12/2016
- Titolare dell'AIC: ABBVIE DEUTSCHLAND GMBH & CO. KG
- Relazione di Valutazione Pubblica Europea (EPAR)
In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Venclyxto monotherapy is indicated for the treatment of CLL:
- in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.