The National Institute for Health and Care Excellence (NICE) has recommended acalabrutinib (Calquence, AstraZeneca) in two combination regimens for untreated blood cancers, offering new first-line options for approximately 790 patients in England with mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL). 

In final draft guidance, NICE recommended acalabrutinib plus bendamustine and rituximab for adults with untreated MCL who are not eligible for an autologous stem cell transplant, and acalabrutinib plus venetoclax for adults with untreated CLL.

The CLL recommendation includes adults with high-risk disease such as 17p deletion or TP53 mutation. Together, the two decisions expand first-line choices for patients whose options may narrow once their disease progresses.

Mantle Cell Lymphoma 

MCL is a rare and aggressive type of non-Hodgkin lymphoma that is considered incurable with current treatments and often recurs. Many patients receive a diagnosis when the disease is already advanced and they are not well enough to undergo stem cell transplantation, which limits their treatment options. 

For MCL, NICE recommended acalabrutinib combined with bendamustine and rituximab for approximately 350 adults who are not eligible for an autologous stem cell transplant.

In the phase 3 ECHO trial, which enrolled 598 patients aged 65 or older with untreated MCL, adding acalabrutinib (100 mg twice daily) to bendamustine and rituximab significantly extended median progression-free survival to 72.5 months, vs 47.8 months with bendamustine and rituximab alone. 

Ruth Lester, a patient representative from Lymphoma Action who is living with MCL, said the decision mattered because people with MCL can have limited options once the disease progresses. She said it was encouraging that a new, better-tolerated treatment option had been recommended, which could allow some patients to spend longer with a better quality of life.

Chronic Lymphocytic Leukaemia 

CLL is the most common type of leukaemia in adults in England and usually progresses slowly but can have a significant physical and psychological effect on daily life. 

For CLL, NICE recommended acalabrutinib in combination with venetoclax, without obinutuzumab, for around 440 adults. The recommendation includes adults with high-risk disease, such as those with 17p deletion or TP53 mutation.

Evidence from the phase 3 AMPLIFY trial showed that acalabrutinib plus venetoclax improved progression-free survival (hazard ratio [HR], 0.65; P = .004) and overall survival (HR, 0.33; P < .001) compared with standard chemoimmunotherapy at a median follow-up of 40.8 months.

Clinical experts said the combination may be better tolerated than existing fixed-duration options and could suit a broader range of patients, including older, fitter individuals. Unlike some treatments requiring intravenous infusion, acalabrutinib plus venetoclax is an all-oral daily regimen, reducing hospital visits and making it easier for patients to fit treatment around daily life. 

NHS Rollout and Patient Impact 

Because it is a cancer treatment, acalabrutinib is funded through the Cancer Drugs Fund and is available to patients in England as soon as final draft guidance is published, under a commercial arrangement that provides a confidential discount.

Helen Knight, director of medicines evaluation at NICE, said the recommendations give patients additional options that can delay disease progression while fitting more easily around everyday life. 

For CLL, the oral, fixed-duration regimen may be easier for some people to manage than treatments requiring regular hospital visits, while fewer intravenous infusions could also help ease pressure on NHS services, particularly in smaller hospitals with limited monitoring or day-unit capacity. NICE noted that the CLL recommendation is consistent with British Society for Haematology guidance supporting both targeted and fixed-duration first-line treatment across risk groups. 

In CLL, the committee concluded that acalabrutinib plus venetoclax was cost effective against relevant first-line comparators, while in MCL adding acalabrutinib to bendamustine and rituximab significantly delayed disease progression in a population with few options once relapse occurs.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

This article was amended on 6 August 2026. An earlier version stated that acalabrutinib must be funded by the NHS in England within 90 days of final guidance publication. As a cancer treatment, acalabrutinib is funded through the Cancer Drugs Fund and is available to patients in England from the point NICE's final draft guidance is published, rather than only after final guidance and the standard 90-day period.