following a full submission:
venetoclax (Venclyxto®) is accepted for restricted use within NHSScotland.
Indication under review: In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
SMC restriction: in patients without del (17p)/TP53 mutation who are fit to receive fludarabine, cyclophosphamide and rituximab (FCR) chemo-immunotherapy.
Venetoclax in combination with obinutuzumab, compared with standard therapies, was associated with clinical benefits in patients who were fit and unfit to receive FCR chemo-immunotherapy.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
For SMC advice relating to the use of venetoclax in (1) patients without del (17p)/TP53 mutation who are not fit to receive FCR chemo-immunotherapy and (2) patients with del (17p)/TP53 mutation, please refer to SMC2293.
- Medicine name:
- venetoclax (Venclyxto)
- SMC ID:
In combination with obinutuzumab (VenG) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- Pharmaceutical company
- AbbVie Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Date advice published
- 09 May 2022