NICE Backs Acalabrutinib for Mantle Cell Lymphoma and Untreated CLL

The National Institute for Health and Care Excellence has endorsed acalabrutinib as an additional treatment option for adults newly diagnosed with mantle cell lymphoma or chronic lymphocytic leukaemia in England.

The decision could expand access to targeted therapy for hundreds of patients, including approximately 440 people with previously untreated chronic lymphocytic leukaemia.

Longer Disease Control in Mantle Cell Lymphoma

Mantle cell lymphoma is an uncommon and fast-growing form of non-Hodgkin lymphoma. Although current therapies can control the disease, it is generally regarded as incurable and frequently returns. Many patients receive their diagnosis after the cancer has advanced and may not be fit enough for a stem cell transplant.

NICE’s recommendation covers acalabrutinib used alongside bendamustine and rituximab. Evidence reviewed by the committee showed that the combination delayed disease progression for a median of 72.5 months. Patients receiving bendamustine and rituximab alone experienced a median progression-free period of 47.8 months.

During the assessment, a patient representative described the emotional impact of being told that the disease could not be cured. They also highlighted the importance of having effective first-line therapies, particularly because treatment choices may become more limited when the lymphoma returns.

New Option for Untreated CLL

NICE has also approved acalabrutinib combined with venetoclax, without obinutuzumab, for adults with untreated chronic lymphocytic leukaemia.

CLL is the most frequently diagnosed form of leukaemia among adults in England. The disease often develops gradually, but its effects can extend beyond physical symptoms, influencing emotional wellbeing, employment, family responsibilities, and everyday activities.

Patient representatives told the committee that treatment decisions are highly personal. Factors such as working arrangements, family commitments, general health, and the need to attend hospital regularly can all influence a person’s preferred treatment approach.

Oral Therapy May Reduce Hospital Visits

Results from the AMPLIFY clinical trial indicated that acalabrutinib combined with venetoclax improved both the time patients lived without disease progression and overall survival when compared with conventional chemoimmunotherapy.

The combination is administered as daily oral medication rather than through an intravenous infusion. For some patients, this may make it easier to organise treatment around work and family life while reducing the number of hospital appointments.

Clinical specialists involved in the NICE review said the regimen was generally well tolerated. Its safety and administration profile could make it appropriate for a wider group of patients, including older adults who remain physically fit.

The recommendation gives clinicians another first-line treatment pathway for two serious blood cancers and may offer patients greater flexibility when choosing care.