Following an abbreviated and full submissions, the Scottish Medicines Consortium has approved Acalabrutinib for CLL with the following restrictions:
*for the treatment of adult patients with previously untreated CLL without a del(17p) or TP53 mutation and who are ineligible for fludarabine, cyclophosphamide and rituximab (FCR) therapy
*previously treated CLL patients (has been approved for those who are not eligible for chemoimmunotherapy).
* untreated patients with 17p deletion or TP53 mutations. These are genetic mutations that affect how well current treatments, such as FCR, work.
Evidence presented showed that Acalabrutinib, compared with chlorambucil-obinutuzumab, significantly improved progression-free survival in adults with previously untreated CLL with co-morbidities.
Jackie