A new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia (CLL) has been approved for use on the NHS.
The treatment has gained provisional support from the National Institute for Health and Care Excellence (NICE), which advises the NHS on the adoption of new treatments.
In final draft guidance, NICE recommends venetoclax plus obinutuzumab as a new fixed 12-month chemotherapy-free treatment for people with CLL who have not received any prior treatments.
Venetoclax plus obinutuzumab will be offered as a first-line treatment to people with CLL who have certain genetic abnormalities such as a 17p deletion or TP53 mutation, according to the guidance.
It will also be available for CLL patients without a 17p deletion or TP53 if fludarabine plus cyclophosphamide and rituximab (FCR) or bendamustine plus rituximab (BR) is unsuitable.
In addition, NICE has recommended that venetoclax plus obinutuzumab be made available through the Cancer Drugs Fund for other people with untreated CLL, namely those without a 17p deletion or TP53 mutation for whom FCR or BR is suitable. It said it is offering this so that more evidence can be gathered on its cost effectiveness in this group, allowing a final decision at a later stage. The Cancer Drugs Fund is used to pay for new treatments in advance of NICE approval.
Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, described the recommendation as good news for people with CLL, adding: “We are pleased the company engaged with NICE and NHSE/I to agree a commercial arrangement that will ensure access to this valuable new treatment option.”
NICE has previously recommended venetoclax with rituximab for adults with relapsed or refractory CLL.
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