- Blood cancer is a significant health burden in Australia with unique challenges for patients and their families. Over 19,400 people are diagnosed with blood cancer every year with more than 135,000 blood cancer survivors living across Australia.1 Blood cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death after lung cancer.1
- Mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), and small lymphocytic lymphoma (SLL) are types of blood cancer that require long term treatment. Patients may be diagnosed with relapsed/refractory MCL, CLL or SLL, which means that the disease has either come back after a time of remission (relapse) or the disease has not responded to treatment (refractory).2
- The tablet formulation for CALQUENCE® acalabrutinib (as maleate monohydrate) will be listed on the PBS from 1 July 2023 for relapsed/refractory CLL/SLL and relapsed/refractory MCL. CALQUENCE® capsules are already available on the PBS for eligible patients.
Australians living with relapsed/refractory mantle cell lymphoma (MCL), relapsed/refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) will have reimbursed access to a tablet form of CALQUENCE® (acalabrutinib as maleate) on the Pharmaceutical Benefits Scheme (PBS) from 1 July 2023. Previously patients prescribed CALQUENCE® took a capsule form of the treatment.
The new CALQUENCE® tablet is film-coated and smaller than the CALQUENCE® capsule3, which for many patients makes it easier to swallow, and can be taken with acid-reducing medicines used to treat gastric acid or reflux.3 The tablet formulation has been developed by AstraZeneca in response to feedback from patients, pharmacists and clinicians.
Patients diagnosed with blood cancer may experience some degree of weight loss or decrease of muscle mass, which can play a role in either uncovering, or exacerbating, underlying gastric acid or reflux.4
Sharon Millman, CEO at Lymphoma Australia, welcomed the availability of CALQUENCE® tablets on the PBS.
“Patients living with lymphoma and CLL often have multiple medical conditions that require them to take many medications at different times each day. The availability of CALQUENCE® in tablet form means that patients can take this treatment at the same time as their other medicines, including medicines to help manage gastro-oesophageal reflux, without the worry of any interactions with other drugs, for the duration of their CALQUENCE® treatment,” said Ms Millman.
AstraZeneca Australia and New Zealand Country President Ben McDonald said the availability of CALQUENCE® in tablet form demonstrates our commitment to addressing the needs of Australian blood cancer patients.
“This practical measure could help to reduce the burden of managing a chronic disease. Our scientists listened to patients about their lived experience with MCL, CLL and SLL and delivered a new option to specifically address their needs,” Mr McDonald said.
CALQUENCE® is registered by the TGA for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy, and for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL).3 CALQUENCE® tablets are now reimbursed for relapsed/refractory CLL/SLL and relapsed/refractory MCL. The new tablet formulation for CALQUENCE® has been demonstrated to be bioequivalent to the currently available capsules.5 CALQUENCE® tablets can be used in place of the current CALQUENCE® capsule formulation. Patients should discuss switching to CALQUENCE® tablets with their prescribing clinician or pharmacist.
Precautions6: 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, use during pregnancy, breastfeeding or if under the age of 18 years.
Interactions6: 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 effects6: 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
| PBS Information: Not listed for TN CLL/SLL. Authority required for R/R CLL/SLL and R/R/ MCL. Refer to PBS. |
- 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 CLL7
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 1000 Australians are diagnosed with CLL each year. It is the most common type of leukaemia diagnosed in Australia.
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.
About SLL8
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 MCL9
Mantle cell lymphoma is a relatively uncommon type of lymphoma, accounting for approximately 5% to 10% of all non-Hodgkin lymphomas. The average age at diagnosis of MCL is 60-65 years. It is two to three times more common in men than in women.
About CALQUENCE®6
CALQUENCE® (acalabrutinib) belongs to a group of anti-cancer medicines called Bruton tyrosine kinase (BTK) inhibitors. BTK is a protein in the body that helps cancer cells to grow. 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 haematological malignancies 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 malignancies, 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 and 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. Lymphoma Australia. 2023. Relapsed and refractory lymphoma. Available at: https://www.lymphoma.org.au/types-of-lymphoma/relapsed-and-refractory-lymphoma/ Accessed 7 June 2023
3. TGA. 2022 CALQUENCE® tablets (acalabrutinib) Approved Product Information Available at https://www.guildlink.com.au/gc/ws/astra/pi.cfm?product=appcaltb11022 Accessed 21 June 2023
4. ASH Clinical News. November 2015. Managing GERD/Acid Reflux: The Gastroenterologist’s Perspective Available: https://ashpublications.org/ashclinicalnews/news/2286/Managing-GERD-Acid-Reflux-The-Gastroenterologist-s Accessed 7 June 2023
5. Sharma S et al. Clin Pharmacol Drug Dev 2022;11:1294–1307
6. 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
7. 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
8. 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.
9. Leukaemia Foundation. 2023. Mantle Cell Lymphoma. Available at: https://www.leukaemia.org.au/blood-cancer/lymphoma/non-hodgkin-lymphoma/mantle-cell-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-16852 June 2023