Eligible people living with Australia’s most common form of lung cancer1 can now access an oral targeted therapy, following AstraZeneca’s TAGRISSO® (osimertinib) being granted an expanded Pharmaceutical Benefits Scheme (PBS) listing.
From 1 July 2026, TAGRISSO® tablets are PBS-reimbursed for the treatment of:
- locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have activating EGFR mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy; and
- locally advanced or metastatic NSCLC for patients whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, for use as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy.
Around 15,000 Australians were diagnosed in 2025 with lung cancer2, Australia’s leading cause of cancer-related death. NSCLC accounts for about 85 per cent of all lung cancers3 and about 18 per cent of NSCLC patients are EGFRm positive.3 EGFR-mutated NSCLC is more common in people with minimal to no smoking history.4,5
Dr Marie Guillet, Country President of AstraZeneca Australia and New Zealand, welcomed the Government’s expanded PBS listing for TAGRISSO, which works by stopping cancer cells with an EGFR mutation from growing and multiplying.6
“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,” Dr Guillet said.
“This expanded PBS listing for TAGRISSO® means reimbursed access for hundreds of additional people living with the most common form of lung cancer.”
Professor Ben Solomon, medical oncologist at the Peter MacCallum Cancer Centre in Melbourne, said: “This PBS listing provides eligible Australian patients with locally advanced or metastatic EGFR-mutated lung cancer with access to a targeted treatment option.
“Access to therapies designed for specific tumour biology is an important consideration in the management of this disease.”
ABOUT TAGRISSO®6
Indication: TAGRISSO® is used for patients with locally advanced, unresectable (stage III) NSCLC whose tumours have activating EGFR mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy; and locally advanced or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, for use as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy.
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: 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
PBS Information7: Authority Required (Streamlined). Refer to PBS Schedule for full Authority Required Information.
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- ENDS-
Professor Ben Solomon has been involved in clinical trials sponsored by AstraZeneca; and has served on advisory boards for which compensation was received. In relation to this media announcement, no compensation was provided to Professor Solomon and the opinions expressed are his own. Professor Solomon has been briefed by AstraZeneca on the approved use of this product.
Media Contacts
AstraZeneca Australia
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 the leading cause of cancer death and the fifth most common cancer diagnosed in Australia. It is responsible for almost one in five cancer deaths in Australia. It is estimated that 15,000 people were diagnosed with lung cancer in 2025.2
There are two main types of primary lung cancer: non-small cell lung cancer (NSCLC) accounting for approximately 85% of all diagnoses, and small-cell lung cancer (SCLC), which accounts for approximately 15%.3
About TAGRISSO®6
Containing the active ingredient osimertinib mesylate, 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 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 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
- Lung cancer types. Cancer Council. Available at: https://www.cancer.org.au/cancer-information/types-of-cancer/lung-cancer Accessed June 2026
- Cancer Australia. Lung Cancer. https://www.canceraustralia.gov.au/cancer-types/lung-cancer/lung-cancer-australia-statistics Accessed June 2026
- Pan et al Rapidly evolving therapeutic advances for classical EGFR-mutant NSCLC www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1732467/full Accessed June 2026
- Gutta, et al, Racial Diversity and Co-Mutational Analysis of Biologically Relevant Alterations in EGFR Mutant Lung Cancers, Clinical Lung Cancer, Volume 26, Issue 4, 2025, Pages 307-313.e7, https://doi.org/10.1016/j.cllc.2025.02.008. Available at: https://www.sciencedirect.com/science/article/abs/pii/S1525730425000385?via%3Dihub Accessed June 2026
- Muthusamy et al EGFR mutation testing, treatment and survival in stage I-III non-small cell lung cancer: CancerLinQ Discovery database retrospective analysis. Future Oncol. 2024;20(28):2083-2096. doi: 10.1080/14796694.2024.2347826. Epub 2024 Jun 25. PMID: 38916211; PMCID: PMC11497985. Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC11497985/ Accessed June 2026
- TAGRISSO CMI https://medsinfo.com.au/consumer-information/document/Tagrisso_CMI#464872-body
- www.pbs.gov.au
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-25593 June 2026