Australians who require their first treatment for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) will have reimbursed access to targeted therapy CALQUENCE® acalabrutinib (as maleate monohydrate) on the Pharmaceutical Benefits Scheme (PBS) from 1 January 2024.
- Blood cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death after lung cancer.1 More than 19,400 people are diagnosed with blood cancer every year with more than 135,000 blood cancer survivors living across Australia.1
- CLL and SLL are types of blood cancer that often require long term treatment. Australians diagnosed with CLL/CLL are more likely to be aged over 60 years old and will manage their disease over many years.2
- CALQUENCE® acalabrutinib (as maleate monohydrate) tablets will be listed on the PBS from 1 January 2024 for use as monotherapy or in combination with obinutuzumab (a type of cancer treatment) for the treatment of previously untreated CLL or SLL. This is an additional listing for CALQUENCE®. CALQUENCE® is already available on the PBS for relapsed/refractory CLL/SLL.
CLL develops when the body makes too many abnormal white blood cells. These abnormal white cells are known as leukaemia cells.3 CLL usually develops and progresses slowly, over months and years.4 Patients who are required to start treatment, with the aim of controlling their disease, will explore different options with their medical specialist before deciding on the most suitable treatment for their disease.5
Targeted cancer drugs may change the way that cancer cells work and can help the body control the growth of cancer.6 One of these types of targeted therapies is called Bruton tyrosine kinase (BTK) inhibitors6. BTK, a protein found in normal and cancer cells, helps cancer cells to survive and reproduce8. CALQUENCE® works as a targeted therapy by blocking BTK, which may help to reduce the number of cancer cells and may slow the spread of the cancer.7
AstraZeneca has delivered cancer medicines to Australians for more than 40 years. Ben McDonald, Country President of AstraZeneca Australia and New Zealand, said:
“The expanded PBS listing of targeted therapy CALQUENCE® provides another treatment option for Australian patients who are living with CLL and SLL and require long term treatment.
“Through research and development, our aim is to improve diagnosis, treatment and management of blood cancers that impact 135,000 Australians each year1,” Mr McDonald said.
“I would like to acknowledge and thank the Australian clinical experts, patient groups, patients and their families who we work alongside to support the thousands of Australians living with blood cancers.”
Professor John Seymour AM, clinical haematologist and the Director of the Haematology Department of the Peter MacCallum Cancer Centre and the Royal Melbourne Hospital, welcomed the addition of CALQUENCE® on the PBS for CLL and SLL patients as a first treatment option, that is, patients who have not yet received treatment for their disease.
“From my years of clinical practice, I understand how important it is for patients to have treatment options available to help them to manage the progression and symptoms of CLL and SLL. These patients are often in the later stages of life and may be seeking reassurance for treatments that will not only help control their disease but also improve their health and wellbeing,” said Professor Seymour.
“CALQUENCE® will now be another reimbursed treatment option patients can consider when their specialist discusses their initial treatment plan with them.”
Sharon Winton, CEO of Lymphoma Australia, also welcomed expanded access to CALQUENCE® on the PBS for Australian patients.
“It’s important for our patient community to have reimbursed access to as many treatment options as possible to address their type of blood cancer. CLL and SLL patients live with a chronic condition and many may need treatment for years, even decades2,” said Ms Winton.
“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.”
CALQUENCE®7 is an anticancer medicine used in adults to treat:
- Mantle Cell Lymphoma (MCL), a type of blood cancer that affects the lymph nodes (lymph glands). It is used in patients who have had at least one other treatment for their cancer.
- CLL and SLL, a type of blood cancer that affects lymphocytes (a certain type of white blood cell) and the lymph nodes.
Precautions7: 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.
Interactions7: 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®. Please discuss with your health professional.
Side effects7: Very common or common side effects include: infection, headache, nausea, vomiting, dizziness, stomach pain, diarrhoea, constipation, rash, bruising, fatigue, muscle and bone pain, joint pain, new cancers including skin cancer.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need treatment if you get some of the side effects. Ask your doctor to answer any questions you may have.
Full Consumer Medicine Information can be accessed at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2019-CMI-02286-1&d=20230528172310101
Refer to PBS schedule for PBS listing Information.
- ENDS-
Media Contacts
AstraZeneca Australia
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 leukaemic cells. CLL usually develops slowly and progresses slowly, over months and years.
Approximately 2,400 Australians are diagnosed with CLL each year9. It is the most common type of leukaemia diagnosed in Australia.4
Almost 80 per cent of all new CLL cases are diagnosed in people who are over the age of 60 and occurs more frequently in men than in women.4
About SLL10
SLL (small lymphocytic lymphoma) is an indolent (slow growing) non-Hodgkin lymphoma that affects B cells. Around 300 Australians will be diagnosed with SLL each year representing five per cent of all lymphomas.
About CALQUENCE®7
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.8 CALQUENCE® works by blocking BTK which may help to reduce the number of cancer cells and may slow the spread of the cancer.
AstraZeneca in Haematology
AstraZeneca is striving to become a scientific leader in haematology by pushing the boundaries of science to transform care for the thousands of Australians living with blood cancers.
Our core focus research areas include a range of blood cancers including different sub-types of leukaemia and lymphoma.
We are partnering with peak health care organisations and patient groups to drive awareness of these hard-to-treat and often rare cancers, in order to improve diagnosis, treatment and management throughout the patient’s long treatment journey, which can last for many years and even decades.
Our clinical research is focused on precision medicines and biomarkers with the aim of matching new treatments to the right patient, while reducing side effects and increasing quality of life benefits.
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 over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com.au
References
1. State of the Nation: Blood Cancers in Australia Report 2023 - Final Report to Leukaemia Foundation. Available https://www.leukaemia.org.au/wp-content/uploads/2023/02/Leukaemia-Foundation_Final-Report_State-of-the-Nation-Blood-Cancers-in-Australia-Report-2023.pdf Accessed 21 June 2023
2. MedicineNet. What is the lift expectancy of someone with CLL. Available at: https://www.medicinenet.com/what_is_the_life_expectancy_of_someone_with_cll/article.htm Accessed 8 December 2023
3. Cancer Council. About CLL. Available: https://www.cancercouncil.com.au/chronic-lymphocytic-leukaemia/about-chronic-lymphocytic-leukaemia-cll/ Accessed 8 December 2023.
4. Leukaemia Foundation. 2023. Chronic lymphocytic leukaemia (CLL) Available at: https://www.leukaemia.org.au/blood-cancer/leukaemia/chronic-lymphocytic-leukaemia/#:~:text=How%20common%20is%20CLL%3F,of%20leukaemia%20diagnosed%20in%20Australia Accessed 21 June 2023
5. Cancer Council. CLL treatment. Available at: https://www.cancercouncil.com.au/chronic-lymphocytic-leukaemia/treatment/ Accessed 8 December 2023.
6. Cancer Research UK. Treatment options for chronic lymphocytic leukaemia (CLL) Available at: https://www.cancerresearchuk.org/about-cancer/chronic-lymphocytic-leukaemia-cll/treatment/decisions Accessed 6 December 2023.
7. TGA. 2023. CALQUENCE® tablets (acalabrutinib) Approved CMI https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2023-CMI-01611-1 Accessed 21 June 2023
8. Hendriks, R., Yuvaraj, S. & Kil, L. Targeting Bruton's tyrosine kinase in B cell malignancies. Nat Rev Cancer 14, 219–232 (2014). https://doi.org/10.1038/nrc3702 Accessed 13 December 2023
9. AIHW. Cancer data in Australia. 2023. Available at: https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/summary-dashboard Accessed 8 December 2023.
10. Leukaemia Foundation. 2023. Small lymphocytic lymphoma Available at: https://www.leukaemia.org.au/blood-cancer/lymphoma/non-hodgkin-lymphoma/small-lymphocytic-lymphoma/ Accessed 21 June 2023.
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-18393 December 2023