AstraZeneca: Kalkvens (acalabrutinib)

Main articles:

• Cancer (cancer)
• Malignant blood diseases

2021: Recommendation as therapy for chronic lymphocytic leukemia

On May 17, 2021, AstraZeneca announced that the Kalkvens drug it developed (acalabrutinib) was recommended by the National Institute health care medical for Care Improvement (NICE) for use English National Health Service (NHS) as a therapy for chronic lymphocytic (leukosis CLL). NICE estimates that about 2,400 patients each year will meet the established criteria for prescribing acalabrutinib. These recommendations will also be accepted by National Services (NHS health care) Wales and Northern. Ireland

In particular, acalabrutinib, a second-generation Bruton tyrosine kinase (TCB) inhibitor, is recommended as a monotherapy option in adult patients with the following conditions:

• previously untreated CLL patients considered at high risk due to certain genetic characteristics (17p deletion or TP53 gene mutation); or
• previously untreated CLL patients who are not at high risk (no 17p deletion or TP53 gene mutation) and cannot receive fludarabine + cyclophosphamide and rituximab (FCR) or bendamustine + rituximab (BR); or
• previously pre-treated CLL patients.

For the first time, patients who have not previously received CLL therapy, who are not at high risk and who cannot receive standard chemotherapy, will have access to targeted oral monotherapy with a TCB inhibitor, while it is important to note that the therapy provided does not require hospitalization. Previously, standard treatment was a combination therapy with intravenous administration of drugs in the hospital. Other CLL patients have had access to TCB inhibitor therapy since 2017.

Recommendations for the use of acalabrutinib are based on the positive results of two phase III clinical studies: ELEVATE-TN involving CLL patients not previously treated, and ASCEND involving patients with recurrent or refractory CLL. Collectively, these studies showed that acalabrutinib significantly reduces the relative risk of disease progression relative to comparison groups in both first-line therapy (patients not previously treated) and the group of CLL patients previously treated. Acalabrutinib was generally well tolerated in both studies.

CLL is the most common type of leukemia in adults, and men are almost twice as likely to develop CLL as women. 41% of cases occur in people aged 75 years and older. It is estimated that about 3,800-4,500 new cases are reported annually in the UK.

Шаблон:Quote 'author = explained Marc Auckland, chairman of the CLL Patient Support Society.

Шаблон:Quote 'author = noted Tom Keith-Roach, President of AstraZeneka UK.

Шаблон:Quote 'author = Arun Krishna, Head of Oncology at AstraZeneka UK.

2020: Registration as monotherapy for the treatment of adult CLL patients in Europe and the UK

Acalabrutinib was registered for use in Europe and the UK in November 2020 as a monotherapy or in combination with obinutuzumab to treat adult CLL patients not previously treated; and as monotherapy for the treatment of adult CLL patients who have previously received at least one type of therapy.