AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) has recommended two acalabrutinib-based combinations, expanding access to new first-line treatment options for eligible adults with mantle cell lymphoma (MCL) and chronic lymphocytic leukaemia (CLL) in England and Wales. For CLL, they introduce the first and only all-oral fixed-duration regimen incorporating a second-generation BTK inhibitor, while for MCL they bring a targeted BTK inhibitor into the first-line treatment pathway for eligible patients.
Dr Toby Eyre (pictured), Consultant Haematologist at Oxford University Hospitals NHS Foundation Trust, said, “We welcome NICE’s recommendation of acalabrutinib plus venetoclax for people living with chronic lymphocytic leukaemia in England.
“This fixed-duration treatment option provides eligible patients with access to an innovative regimen that offers the flexibility of planned time off treatment. Expanding treatment choice through the NHS is an important step forward and may help reduce the burden of therapy while supporting patients to live well with their disease.”
The NICE recommendation makes acalabrutinib plus venetoclax available as an all-oral, fixed-duration first-line treatment option with demonstrated efficacy for eligible patients with previously untreated CLL.
This recommendation is supported by results from the Phase III AMPLIFY trial, in which acalabrutinib plus venetoclax reduced the risk of disease progression or death by 35% compared with standard-of-care chemoimmunotherapy (HR 0.65; 95% CI 0.49–0.87; p=0.0038). At three years after treatment initiation, 77% of patients treated with acalabrutinib plus venetoclax were progression-free, compared with 67% of patients receiving chemoimmunotherapy (investigator’s choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab). 1
Grade 3 or higher AEs occurred in 53.6% of patients treated with acalabrutinib plus venetoclax and 60.6% of patients treated with standard-of-care chemoimmunotherapy. Median PFS was not reached in the acalabrutinib plus venetoclax arm compared with 47.6 months in the chemoimmunotherapy arm.1
Dr David Lewis, Plymouth Hospitals NHS Trust,said: “NICE’s recommendation of acalabrutinib in combination with bendamustine and rituximab as a first-line treatment for mantle cell lymphoma is an important step for patients in England.
“As an incurable disease that mainly affects older people, optimising treatment from the outset is critical. This NHS access decision gives eligible patients the opportunity to benefit from the only targeted treatment currently available in the first-line setting and could help establish a new standard of care for transplant-ineligible patients.”
Dallas Pounds, Director of Services, Lymphoma Action, said: “A blood cancer diagnosis can have a significant impact on every aspect of a person’s life, so having access to a range of effective treatment options is incredibly important.
“These recommendations give eligible people with MCL greater choice, allowing treatment decisions to better reflect each person’s clinical needs, lifestyle and preferences.”
The NICE recommendation for MCL is supported by results from the Phase III ECHO trial which met its primary endpoint, in which acalabrutinib plus bendamustine and rituximab significantly improved progression-free survival compared with placebo plus bendamustine and rituximab (HR 0.73; 95% CI 0.57–0.94; p=0.016). Median progression-free survival was 66.4 months with the acalabrutinib combination compared with 49.6 months with placebo plus bendamustine and rituximab. 2
Overall survival was a key secondary endpoint and data were immature at the time of analysis. The OS difference was not statistically significant (HR 0.86; 95% CI 0.65-1.13; p=0.27). Grade 3 or higher adverse events (AEs) occurred in 88.9% of patients in the acalabrutinib arm and 88.2% in the placebo arm.2
Tom Keith-Roach, Country President, AstraZeneca UK, said: “We welcome NICE’s recommendation of Calquence for patients with MCL and CLL in England and Wales.
“Every step that broadens access to innovation matters as we work towards our bold ambition of eliminating blood cancer as a cause of death. Together with the NHS, we remain focused on bringing meaningful advances to patients as quickly as possible.”
References
[1] Lymphoma Action. Mantle cell lymphoma. Available at: https://lymphoma-action.org.uk/information-and-support/types-lymphoma/non-hodgkin-lymphoma/mantle-cell-lymphoma. Accessed July 2026.
2 Brown JR, Seymour JF, Jurczak W, et al. Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia. New England Journal of Medicine. 2025;392(8):748-762. Available at: https://doi.org/10.1056/NEJMoa2409804. Accessed July 2026.
