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For the first time, patients with untreated, non-high risk CLL who cannot be treated with standard chemotherapy will have access to targeted oral monotherapy.1

• Today’s announcement builds on the draft NICE recommendation from December, where access to acalabrutinib was granted for patients with untreated high-risk CLL or previously treated CLL.1

• CLL is the most common type of blood cancer in adults in the UK but significant unmet treatment needs remain.2

• In clinical trials, acalabrutinib significantly prolonged the time that patients spent in remission (time to disease progression or death) compared with existing treatment options, in both untreated and previously treated patients, whilst being generally well tolerated.3,4

Luton, UK, 18 March 2021 – AstraZeneca has today announced that its oral targeted cancer therapy Calquence (acalabrutinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine use within NHS England as a treatment for chronic lymphocytic leukaemia (CLL).1 NICE estimates that approximately 2,395 patients will be eligible for treatment with acalabrutinib every year. The recommendations will also be adopted by the NHS in Wales and Northern Ireland.

Specifically, acalabrutinib, a second generation BTK inhibitor, is recommended as a monotherapy option for adults with:1 • Untreated CLL who are considered high-risk due to certain genetic characteristics they harbour (17p deletion or TP53 mutation); or • Untreated CLL who are considered non-high risk (no 17p deletion or TP53 mutation), and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR) is unsuitable; or • Previously treated CLL. This is the first time that untreated, non-high risk CLL patients who cannot be treated with standard chemotherapy will have access to targeted oral monotherapy with a BTK inhibitor that can be taken at home. Previously, standard treatment consisted of combination therapy involving intravenous administration in hospital.1 Other patients with CLL have had access to BTK inhibitor therapy since 2017.5

Commenting on today’s announcement, Anna Schuh, Associate Professor and honorary consultant haematologist, University of Oxford, said: “This NICE recommendation has the potential to improve disease outcomes for thousands of patients with CLL in the UK. There has been a significant unmet need for effective, targeted treatments that are well tolerated and that do not require multiple hospital visits, especially for patients in need of treatment for the first time. Acalabrutinib is generally well-tolerated and therefore represents a welcome new treatment option for older and frail patients. The NICE recommendation is therefore excellent news for the CLL community.”

The recommendations for acalabrutinib are based on positive results from the two Phase III clinical trials: ELEVATE-TN in patients with previously untreated CLL, and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that acalabrutinib significantly reduced the relative risk of disease progression versus the comparator arms in both first-line (treatment naïve) and previously treated CLL. Across both trials, acalabrutinib was generally well-tolerated.3,4

CLL is the most common type of leukaemia in adults and men are nearly twice as likely to develop CLL as women. 2,6 41% of cases occur in people aged 75 and over.7 It is estimated that there are around 3,800-4,500 new cases in the UK each year.6

Commenting on what today’s decision means for the patient community, Marc Auckland, Chair of CLL Support, said: “CLL is an incurable blood cancer that until a few years ago could only be treated with standard chemotherapy. New targeted oral drugs are now broadening the options to manage this disease that affects over 20,000 people across the UK.

“The NICE recommendation for acalabrutinib expands treatment options for many people with CLL, with some people being able to access a BTK inhibitor for the first time. This is a great step forward and the challenge now is to understand which treatment to use in what sequence to contain this chronic disease.”

Tom Keith-Roach, President, AstraZeneca UK, said: “Today’s decision by NICE to enable access to acalabrutinib is very welcome. The NHS has made a clear commitment to significantly improve patient outcomes in cancer and providing access to precision medicines like acalabrutinib is an important part of getting back on track post-COVID.”

Arun Krishna, Head of Oncology at AstraZeneca UK, said: “Until recently, standard treatment for less fit, treatment naïve, non-high risk CLL patients was chemo-immunotherapy that is administered in hospital.

“The COVID-19 pandemic made even more acute the need for effective treatments that can be taken at home. In response AstraZeneca enabled early access to acalabrutinib in April 2020 for patients within this at-need population. Today’s welcome news from NICE means that this medicine will now become routinely available to CLL patients within the NHS, helping to improve the outcomes of patients living with this disease.”

Acalabrutinib was licensed for use in Europe and the UK in November 2020 as monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL; and as monotherapy for the treatment of adult patients with CLL who have received at least one prior therapy.8

Further information about the clinical trial data evaluating the efficacy and safety profile of acalabrutinib is provided below, and a full summary of product characteristics can be found here:8

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Last Updated: 18-Mar-2021