europeanpharmaceuticalreviewNovember 16, 2020
Tag: NICE , CLL , obinutuzumab , Venetoclax
The UK’s National Institute for Health and Care Excellence has recommended a new chemotherapy-free treatment for people with untreated chronic lymphocytic leukaemia (CLL). The institute said its recommendation of venetoclax plus obinutuzumab could benefit more than 1,000 people each year.
The innovative 12-month treatment will be offered to people with CLL who have not received any prior treatments. CLL affects white blood cells and is the most common chronic leukaemia, accounting for 30 percent of all adult leukaemias. In England there were 3,157 new cases of CLL in 2017.
Venetoclax plus obinutuzumab will be offered as a first-line treatment to people with CLL, with certain genetic abnormalities (such as a 17p deletion or TP53 mutation). For those without a 17p deletion or TP53 mutation, venetoclax plus obinutuzumab will be offered to patients with untreated CLL for whom fludarabine plus cyclophosphamide and rituximab (FCR) or bendamustine plus rituximab (BR) is unsuitable. The combination has also been made available via the UK’s Cancer Drugs Fund for this indication, so more evidence can be gathered on its cost effectiveness.
Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said: “Today’s announcement is good news for many people with chronic lymphocytic leukaemia. 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.”
Venetoclax is taken orally, once a day for 12 x 28-day cycles. Obinutuzumab is administered intravenously for six 28-day cycles.
NICE has previously recommended venetoclax with rituximab for adults with relapsed or refractory chronic lymphocytic leukaemia.
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