On November 10, 2020, the National Institute for Health and Care Excellence (NICE) recommended venetoclax in combination with obinutuzumab for patients with previously untreated chronic lymphocytic leukemia (CLL).
The guidance published by NICE indicates the routine National Healthcare Service (NHS) use of the venetoclax combination for the following indications:
- Adult patients with CLL with del(17p)/TP53 mutation
- Adult patients with CLL without del(17p)/TP53 mutation who are ineligible for treatment with fludarabine, cyclophosphamide, and rituximab (FCR) or bendamustine and rituximab (BR)
NICE has also recommended the use of venetoclax + obinutuzumab within the Cancer Drugs Fund for adult patients with CLL without del(17p)/TP53 mutation who are eligible for FCR or BR.
This approval provides a chemotherapy-free, 1-year fixed duration, first-line treatment option for patients with CLL, and will be available immediately to NHS patients in England.
The decision follows positive data from the phase III CLL14 trial (NCT02242942), which uncovered the superiority of venetoclax + obinutuzumab over chlorambucil + obinutuzumab in prolonging progression-free survival in patients with previously untreated CLL. For a comprehensive summary of the study design and efficacy outcomes from the CLL14 study, click here. The Lymphoma Hub also provided an overview of the full safety profile of the two regimens employed in the CLL14 trial, read it here.