Eligible Australians requiring their first treatment for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) now have access to CALQUENCE® (acalabrutinib) tablets on the Pharmaceutical Benefits Scheme (PBS).
From 1 June 2026, hundreds of patients per year who are living with previously untreated CLL or SLL will have reimbursed access to CALQUENCE® tablets in combination with venetoclax (another type of anti-cancer tablet) for a defined treatment period.
- Blood cancer is the third most commonly diagnosed cancer and the second leading cause of cancer-related death, after lung cancer2. Around 20,000 people were diagnosed with blood cancer in Australia in 20252, and more than 135,000 Australians currently live with blood cancer.2
- Around 2,400 Australians are diagnosed annually with CLL3, which develops when the body makes too many abnormal white blood cells, also known as leukaemia cells.3
- People living with CLL and SLL are more likely to be aged over 60 and will manage their disease over many years.4
CALQUENCE® belongs to a group of anti-cancer medicines called Bruton tyrosine kinase (BTK)5 inhibitors. BTK is a protein in the body that helps cancer cells to grow.5 CALQUENCE® works by blocking BTK, which may help to reduce the number of cancer cells and may slow the spread of the cancer.5
AstraZeneca has delivered innovative cancer medicines to Australians for more than 40 years. AstraZeneca Australia and New Zealand’s Country President, Dr Marie Guillet, said: “Blood cancers are complex and challenging to treat, and many patients experience long treatment journeys and limited options.
“AstraZeneca welcomes the Australian Government’s investment in this expanded listing, which will provide hundreds of additional patients per year with PBS access to CALQUENCE® as their first treatment option.”
Dr Wojt Janowski, a clinical haematologist at Calvary Mater Newcastle Hospital, welcomed the expansion of CALQUENCE’s PBS listing, noting: “The more reimbursed treatment options that people with CLL and SLL have access to, the better.
“Given that many people living with CLL and SLL are older and may spend years managing their condition, having an additional first-line treatment option for their unique circumstance is appreciated.”
In welcoming expanded PBS access to CALQUENCE®, Sharon Winton, CEO of Lymphoma Australia, said: “People with CLL and SLL live with a chronic condition and may require treatment for years and even decades4, which makes it important for them to have reimbursed access to as many treatment options as possible.
“Our hope is that the inclusion of targeted therapies, like CALQUENCE®, on the PBS will help our patient community in the management of their disease and provide some reassurance that affordable treatment options are available to them when they need it.”
ABOUT CALQUENCE®:
Indication: CALQUENCE® for use in a fixed-duration regimen in combination with venetoclax for eligible patients with previously untreated CLL or SLL.
Precautions5: Patients should inform their doctor if they have any of the following medical conditions: bleeding, infections, liver problems, liver infection, heart rhythm problems, any other medical condition, or if they have recently undergone/plan to have surgery, plan to become pregnant or are breastfeeding or if they are under the age of 18 years.
Interactions5: Some medicines used to treat heart rhythm disturbances, fungal infections, HIV, hepatitis C, epilepsy, diabetes and other cancers, some antibiotics, medicines that increase the risk of bleeding including some medicines used to treat pain and inflammatory conditions or to prevent blood clots, and St John’s Wort may interfere with CALQUENCE®. Patients should discuss with their health professional.
Side effects5: Common side effects may include infection, headache, nausea, vomiting, dizziness, stomach pain, diarrhoea, constipation, rash, bruising, bleeding, fatigue, muscle and bone pain, joint pain, and new cancers including skin cancer.
Full Consumer Medicine Information can be accessed at: www.medsinfo.com.au/consumer-information/document/Calquence_CMI?drug_id=15583&documenttype=cmi#493201-body
Refer to PBS schedule6 for PBS listing Information.
- ENDS-
Dr Wojt Janowski has been involved in clinical trials sponsored by AstraZeneca. In relation to this media announcement, no compensation was provided to Dr Janowski, and the opinions expressed are his own. Dr Janowski has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia anzmedia@astrazeneca.com
CALQUENCE® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au.
For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com
Notes to editors
About CLL4
Chronic lymphocytic leukaemia (CLL) is a type of slow-growing leukaemia that affects developing B-lymphocytes (also known as B-cells – specialised white blood cells). Normally B-cells produce immunoglobulins (also called antibodies) that help protect against infection and disease. In patients with CLL, lymphocytes undergo a malignant change and become leukaemia cells. CLL usually develops slowly and progresses slowly, over months and years.
Approximately 2,400 Australians3 are diagnosed each year with CLL, one of the most common types of chronic leukaemia in Australia.3
CLL mostly affects people over the age of 60, occurring more frequently in men than in women.4
About SLL4
Less common than CLL, small lymphocytic lymphoma (SLL) is a slow-growing, non-Hodgkin lymphoma that affects B cells.
About CALQUENCE®5
CALQUENCE® (acalabrutinib) belongs to a group of anti-cancer medicines called Bruton tyrosine kinase (BTK) inhibitors. BTK, a protein found in normal and cancer cells, helps cancer cells to survive and reproduce.5 CALQUENCE® works by blocking BTK, which may help to reduce the number of cancer cells and may slow the spread of the cancer.
About VENETOCLAX7
Venetoclax (also called Venclexta) is a type of targeted therapy drug called a BCL2 inhibitor. Some leukaemia or cancer cells make too much of a protein called BCL2 which prevents the leukaemia or cancer cells from dying, so they continue to grow. Venetoclax blocks the BCL2 protein and may help to destroy the leukaemia or cancer cells.
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com.au
References
1. Australian Institute of Health and Welfare www.aihw.gov.au/getmedia/ea870f59-a9e4-4772-8fa8-e1206b56a552/cancer-data-in-australia.pdf?v=20251106142816&inline=true Accessed 18 May 2026
2. State of the Nation: Blood Cancers in Australia Report 2023 - Final Report to Leukaemia Foundation. Available www.leukaemia.org.au/wp-content/uploads/2025/10/Leukaemia-Foundation_Final-Report_State-of-the-Nation-Blood-Cancers-in-Australia-Report-2023.pdf Accessed 11 May 2026
3. Cancer Council. About CLL. Available: www.cancercouncil.com.au/chronic-lymphocytic-leukaemia/about-chronic-lymphocytic-leukaemia-cll/ Accessed 11 May 2026
4. Lymphoma Australia. CLL and SLL. www.lymphoma.org.au/types-of-lymphoma/non-hodgkin-lymphoma/indolent-slow-growing-b-cell-nhl/chronic-lymphocytic-leukemia-cll/ Accessed 11 May 2026
5. CALQUENCE CMI www.medsinfo.com.au/consumer-information/document/Calquence_CMI?drug_id=15583&documenttype=cmi#493201-body Accessed 11 May 2026
7. www.tga.gov.au/sites/default/files/auspar-venetoclax-220426-pi.pdf Accessed 11 May 2026
AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com | AU-25225 May 2026