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.

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). 

Dr. Toby Eyre, 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.”

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.”