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NICE recommends BeiGene’s treatment for chronic lymphocytic leukemia

The National Institute for Health and Care Excellence (NICE) has issued a final draft guidance (FDG) recommending Brukinsa® (zanubrutinib) for the treatment of eligible adult patients with:

Untreated chronic lymphocytic leukemia (CLL) if there is a 17p deletion or TP53 mutation (high risk) or
Untreated CLL without a 17p deletion or TP53 mutation, and fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus rituximab (BR) is unsuitable and
Relapsed or refractory CLL.

As stated in the FDG, for the untreated CLL population that is high-risk or for whom FCR or BR is unsuitable and for the relapsed/refractory CLL population, zanubrutinib was dominant (had lower incremental costs and more incremental QALYs) compared with ibrutinib and acalabrutinib. The committee considered that zanubrutinib is a cost-effective use of NHS resources in CLL. Brukinsa is the third BTKi for CLL to be recommended by NICE for routine commissioning.

In addition, on 9 October 2023, BRUKINSA received approval by the Scottish Medicines Consortium for the treatment of adult patients with CLL in whom chemo-immunotherapy is unsuitable.

Dr. Robert Mulrooney, General Manager, UK & Ireland at BeiGene said: “We are delighted that NICE has recognised the clinical and economic benefit of BRUKINSA for patients with CLL. This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia. Although we are a relatively new player in the UK market, we are rapidly establishing ourselves as a company that can make innovative cancer medicines accessible and affordable for UK patients.”

Debbie Yates, Trustee, CLL Support said: “We welcome this decision as it represents a significant milestone for patients in England and Wales with CLL, the most common form of leukaemia. Despite continued treatment advances, many patients with CLL will relapse and need additional treatment options. Additionally, a proportion of patients have a disease which is refractory to initial treatment.”

Dr. Talha Munir, consultant hematologist at Leeds Teaching Hospitals NHS Trust, Leeds, UK said: “Zanubrutinib has demonstrated superior efficacy and a favourable safety profile in two global Phase 3 trials, SEQUOIA and ALPINE, in adult patients with CLL1,2. The positive recommendation from NICE will allow patients with CLL in England and Wales to access this important new treatment option.”


1 Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2023;388(4):319-332. doi: 10.1056/NEJMoa2211582.

2 Tam CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043. doi: 10.1016/S1470-2045(22)00293-5.


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