BeiGene, Ltd. announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA® (zanubrutinib) for the treatment of eligible adult patients with: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
“We are delighted that NICE has recognized the clinical and economic benefit of BRUKINSA for patients with CLL,” said Dr. Robert Mulrooney, General Manager, U.K. & Ireland at BeiGene. “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 U.K. market, we are rapidly establishing ourselves as a company that can make innovative cancer medicines accessible and affordable for U.K. patients.”
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 had lower incremental costs and more incremental quality adjusted life years compared with other BTK inhibitors. The committee considered that zanubrutinib is a cost-effective use of NHS resources in CLL.
“This decision represents a significant milestone for patients in England and Wales with CLL, the most common form of leukemia in adults,” said Nick York, Patient Advocacy Healthcare Liaison Officer, U.K. Leukemia Care. “Despite continued treatment advances, many patients with CLL will relapse and need additional treatment options. Furthermore, a proportion of patients have a disease which is refractory to initial treatment.”
BRUKINSA is the third BTKi for CLL to be recommended by NICE for routine commissioning.
“Zanubrutinib has demonstrated superior efficacy and a favorable safety profile in two global Phase 3 trials, SEQUOIA and ALPINE, in adult patients with CLL,” said Dr. Talha Munir, consultant hematologist at Leeds Teaching Hospitals NHS Trust, Leeds, U.K.i,ii “The positive recommendation from NICE will allow patients with CLL in England and Wales to access this important new treatment option.”
In addition, on October 9, 2023, BRUKINSA received approval by the Scottish Medicines Consortium for the treatment of adult patients with CLL in whom chemo-immunotherapy is unsuitable.
BRUKINSA is approved in more than 65 countries, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland, in selected indications and under development for additional indications globally. The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.
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