AbbVie’s Venclyxto (venetoclax) has been recommended for use by the National Institute of Health and Care Excellence (NICE) as a routine treatment for chronic lymphocytic leukaemia (CLL).
The oral B-cell lymphoma-2 (BCL-2) inhibitor has been indicated for use in combination with Roche’s Gazyvaro (obinutuzumab) for CLL patients who have not received prior treatment.
In particular, NICE has recommended Venclyxto plus Gazyvaro for routine NHS use in CLL patients with del(17p)/TP53 mutation and those without del(17p)/TP53 mutation for whom cyclophosphamide and rituximab (FCR) or bendamustine and rituximab (BR) are unsuitable.
As well as this indication, NICE has also recommended the Veclyxto combination treatment for use within the Cancer Drugs Fund (CDF) for patients without without del(17p)/TP53 mutation and for whom FCR or BR are suitable.
“As a company, our mission is to have a remarkable impact on people's lives – and we know we cannot go it alone,” said Belinda Byrne, medical director at AbbVie UK.
“We have worked closely with NICE, NHS England and the clinical and patient community to ensure all CLL patients have access to venetoclax in the frontline setting as quickly as possible. This decision recognises the benefit of venetoclax for both CLL patients and the NHS,” she added.
The phase III CLL14 trial confirmed sustained progression-free survival (PFS) of the Vencylxto plus Gazyvaro combination versus Gazyvaro plus chlorambucil, a type of chemotherapy, in previously untreated patients with CLL and coexisting medical conditions.
At three years the estimated PFS rate for the Venclyxto plus Gazyvaro combination was 81.9% compared to the PFS of 49.5% for patients taking commonly used chemoimmunotherapy chlorambucil-obinutuzumab (ClbG).