More Australians living with non-small cell lung cancer (NSCLC) will now be able to access a targeted therapy on the Pharmaceutical Benefits Scheme (PBS) from 1 June 2024 following the PBS listing of TAGRISSO® (osimertinib mesilate) for eligible patients.1
TAGRISSO® will be reimbursed for the treatment of patients with early-stage (Stage IB to IIIA) epidermal growth factor receptor mutation (EGFRm) positive NSCLC as adjuvant therapy after surgical resection.1
- Lung cancer is the leading cause of cancer death in Australia. More than 14,000 Australians are diagnosed with lung cancer each year.2
- NSCLC accounts for approximately 85% of all lung cancers.2 Approximately 18% of NSCLC patients are EGFRm positive.3
- Approximately 25-30% of all patients with NSCLC are diagnosed early enough to have surgery with curative intent; however many of these patients eventually develop disease recurrence (often in the central nervous system (CNS)) despite the surgical removal of the tumour and chemotherapy post-surgery.4,5,6
- The current treatment for early-stage EGFRm NSCLC post-surgery is either chemotherapy or 'watch and wait'.7
- Early-stage NSCLC has unacceptably high rates of recurrence, 45% in Stage Ib and 76% in Stage IIIa.8 People with early-stage EGFRm NSCLC are in urgent need of new treatment options.
- TAGRISSO® works by stopping cancer cells with a defect (mutation) in a gene called EGFR (epidermal growth factor receptor) from growing and multiplying.9
- Genetic testing can help guide the most appropriate treatment, for example testing for EGFRm status in lung cancer is important as it can determine whether a targeted therapy like TAGRISSO® may be suitable.
Ben McDonald, Country President of AstraZeneca Australia and New Zealand, which has delivered life-saving cancer medicines to Australians for over 40 years, said:
“We welcome the listing of TAGRISSO® on the PBS for patients diagnosed with early-stage EGFRm non-small cell lung cancer following surgery, Mr McDonald said.
“With the national lung cancer screening program to begin next year, patients need more treatment options for earlier stage diagnosis.
“Thank you to the Australian clinicians and patients that have been involved in the clinical trials for this indication, working tirelessly to have this treatment available on the PBS for this type of lung cancer,” Mr McDonald said.
Professor Tom John, Medical Oncologist from Peter MacCallum Institute who treats patients with non-small cell lung cancer said:
“The inclusion of TAGRISSO® on the PBS after curative surgery for lung cancer is a significant step for patients with lung cancer with an EGFR mutation.
“This treatment specifically targets the mutation in these tumour cells. It is exciting that Australia is in line with other countries in reimbursing this treatment.”
Lung Foundation Australia CEO, Mark Brooke, welcomes the addition of the early-stage non-small cell lung cancer treatment onto the PBS.
“The addition of new treatments to the PBS for early-stage EGFRm patients is warmly welcomed by the Lung Foundation and thousands of lung cancer patients nationwide.
“Lung cancer is the leading cause of cancer death in Australia, so patients eagerly await treatments added to the PBS saving them valuable money, but more importantly giving them hope.”
ABOUT TAGRISSO®9
Indication: TAGRISSO® is used for the treatment of early-stage epidermal growth factor receptor mutation (EGFRm) positive non-small cell lung cancer (NSCLC) as adjuvant therapy after surgical resection.
Precautions: Patients should inform their doctor if they have any of the following medical conditions: interstitial lung disease, pneumonia or other lung problems, heart problems or risk factors for heart problems, other medical conditions. Patients should inform their doctor if they are pregnant or plan to have a baby (male or female), are breastfeeding or intending to breastfeed, or if under the age of 18 years. Patients should inform their doctor if they use or intend to use contact lenses during treatment or if they have allergies to any other medicines, foods, preservatives or dyes.
Interactions: Patients should inform their doctor if they are taking any other medicines, including any medicines, vitamins, or supplements without a prescription from a pharmacy, supermarket or health food shop.
Side effects: Very common side effects include: diarrhoea, rash, musculoskeletal pain, nail toxicity, dry skin, stomatitis, feeling weak or tired and cough.
More information can be found in the TAGRISSO® Consumer Medicine Information here: https://medsinfo.com.au/consumer-information/document/Tagrisso_CMI#464872-body
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at http://www.tga.gov.au/reporting-problems.
PBS Information1: Authority Required (Streamlined). Refer to PBS Schedule for full Authority Required Information. |
- ENDS-
Professor John has been involved in clinical trials sponsored by AstraZeneca; and has served on advisory boards for which compensation was received. In relation to this AstraZeneca media announcement, no compensation was provided to Professor John and the opinions expressed are his own. Professor John has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
anzmedia@astrazeneca.com
TAGRISSO® is a trademark of the AstraZeneca group of companies. 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
Lung cancer in Australia
Lung cancer is Australia’s biggest cancer killer, with a five-year survival rate of 20.2%, the lowest of the five most common cancers. It is responsible for almost one in five cancer deaths in Australia.2,10
It is estimated that approximately 14,700 people will be diagnosed with lung cancer each year.2
Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and small cell lung cancer. NSCLC accounts for ~85% of all lung cancers.2 The majority of all NSCLC patients are diagnosed with advanced disease, while approximately 25-30% of patients with NSCLC are diagnosed early enough to have surgery with curative intent. However, many of these patients eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.
About TAGRISSO®11
TAGRISSO® contains the active ingredient osimertinib mesilate. TAGRISSO® is a tyrosine kinase inhibitor (TKI). It works by stopping cancer cells with a defect (mutation) in a gene called EGFR (epidermal growth factor receptor) from growing and multiplying. It may also help prevent the tumour from coming back after the tumour(s) have been removed by surgery or when the cancer is advanced and is worsening. TAGRISSO® is currently reimbursed for patients with locally advanced or metastatic NSCLC with an EGFR mutation.
TAGRISSO® is prescribed and administered to patients in tablet form and taken orally.
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. Pharmaceutical Benefits Advisory Committee Meeting Outcomes November 2023 https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/pbac-outcomes/2023-11/pbac-web-outcomes-11-2023-v2.pdf Accessed May 2024
2. Lung cancer. Cancer Council. Available at: https://www.cancer.org.au/cancer-information/types-of-cancer/lung-cancer Accessed May 2024
3. Drug utilisation sub-committee Paper, Erlotinib and Gefitinib: 24 month predicted versus actual analysis. Available at: https://www.pbs.gov.au/pbs/industry/listing/participants/public-release-docs/2017-02/erlotinib-and-gefitinib-non-small-call-lung-cancer-feb-2017 Accessed May 2024
4. Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell Lung Cancer: Where is it Going? Ann Oncol. 2010;21:196-8. Available at https://pubmed.ncbi.nlm.nih.gov/20943614/ Accessed May 2024
5. Pignon JP, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26:3552-3559. https://ascopubs.org/doi/10.1200/JCO.2007.13.9030
6. Peters, S et al, The impact of brain metastasis on quality of life, resource utilization and survival in patients with non-small cell lung cancer. Available at: https://www.sciencedirect.com/science/article/pii/S0305737216000426?via%3Dihub Accessed May 2024
7. Tsuboi, M et al. Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. The New England Journal of Medicine. Available at https://www.nejm.org/doi/full/10.1056/NEJMoa2304594 Accessed May 2024
8. Wu YL et al. ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer N Engl J Med 2020;383:1711-1723. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2027071 Accessed May 2024
9. TAGRISSO® Consumer Medicine Information (CMI) Available at: https://medsinfo.com.au/consumer-information/document/Tagrisso_CMI#464872-body Accessed May 2024
10. Lung Foundation Australia. 2022. The Next Breath: Accelerating Lung Cancer Reform. Available at: https://lungfoundation.com.au/wp-content/uploads/2022/08/OYO220615_LFA_Lung-Cancer-Blueprint-2_Digital.pdf
11. TGA Approval 2021. Product information for TAGRISSO®. Available at: https://medsinfo.com.au/api/documents/Tagrisso_PI?format=pdf Accessed May 2024
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-19706 May 2024