04 April 2022

Men in Australia with one of the most aggressive forms of advanced prostate cancer will now have a new PBS listed treatment option

From April 2022, AstraZeneca’s Lynparza® (olaparib) will be the first targeted treatment listed on the PBS for men living with advanced prostate cancer linked to a BRCA gene mutation (BRCAm) – an aggressive and incurable form of cancer1,2

  • More than 18,110 men were diagnosed with prostate cancer in 2021.3 Prostate cancer remains the most commonly diagnosed cancer in men and the second most common cause of cancer-related death in men in Australia.4
  • One of the most aggressive forms of prostate cancer is associated with BRCA mutations5,6,7, a gene mutation which is more commonly associated with women with breast and ovarian cancer.8 BRCA mutations affect 10-12% of men with metastatic castration- resistant prostate cancer (mCRPC).5,9,10
  • Lynparza is a targeted treatment now available on the PBS for this patient population, and works as a ‘PARP inhibitor’. Poly (ADP-ribose) polymerases (PARPs) are proteins in the body that can help cancer cells grow and survive. Lynparza works by blocking the activity of these proteins, making it difficult for cancer cells to survive.11

PCFA welcomes today’s announcement about the April listing of Lynparza® (olaparib) on the Pharmaceutical Benefits Scheme (PBS) for the treatment of men with BRCA mutated (germline and/or somatic) castration resistant metastatic carcinoma of the prostate who have progressed following prior therapy that included a novel hormonal agent.1

A daily oral medicine, Lynparza is the first targeted treatment available on the PBS for men with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) and can be taken at home without the need to attend a hospital or medical setting to administer.2

With Lynparza now available on the PBS as a targeted treatment for men with BRCA-mutated mCRPC that has progressed on novel hormone therapy, it’s important that patients are aware of their BRCA mutation status by getting tested, to determine if they are eligible for a treatment that specifically targets their type of cancer.12 Identifying BRCA-mutations in mCRPC as early as possible has the potential to change the way this disease is treated in this patient population.

Associate Professor Shahneen Sandhu of Peter MacCallum Cancer Centre said: “Molecular testing has been done for a long time in many other cancers such as lung, colorectal and melanoma and now should also be routinely discussed with patients with advanced prostate cancer.

“Unfortunately, patients with mCRPC often have disease related symptoms such as bone pain and tiredness that can affect their quality of life. It is great news that men with aggressive BRCA1/2 mutant advanced prostate cancer will now be able to access another treatment option on the PBS.”

In Australia, one in six men will be diagnosed with prostate cancer by the age of 85.13 It is more common in older men, with more than 63% of cases diagnosed in men over 65 years of age.13 By 2040, it is predicted there will be 372,000 men living with prostate cancer, or in remission, in Australia.4

mCRPC is an advanced, aggressive form of prostate cancer. It includes cancers where the tumour has spread, or metastasised, to other areas in the body and are no longer responding to hormone therapy.14

Prostate Cancer Foundation of Australia Chief of Mission and Head of Research, Professor Jeff Dunn AO, said, “This listing will be welcomed by the hundreds of Australian men and families who are living with advanced prostate cancer. We commend the Australian Government for expanding access to affordable medicines and look forward to supporting eligible men commencing treatment on Lynparza as soon as they need it.”

Men diagnosed with prostate cancer who have mutations in the BRCA1 or BRCA2 gene have been associated with a more aggressive disease and poor clinical outcomes.7,8 In particular, men with faults in their BRCA2 gene are five times more likely to be diagnosed with prostate cancer and at a younger age.15 This high-risk group is twice as likely to have a more serious, potentially life-threatening, form of prostate cancer.16

Benjamin McDonald, Country President, AstraZeneca Australia & New Zealand, said “We are delighted that Lynparza has been listed on the PBS for men diagnosed with this aggressive form of prostate cancer. AstraZeneca is committed to ensuring patients with hard-to-treat cancers have access to new treatment options that will help them. For 65 years, AstraZeneca has been supporting Australians living with chronic, terminal and rare diseases and today’s announcement is another positive step forward in bringing more options to those in need.”

For more information about prostate cancer, and potential risks, people should speak to their healthcare provider.

Before taking LYNPARZA tablets: Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have had any of the following medical conditions: problems with your kidneys or liver (renal or hepatic impairment) or problems with your blood (e.g. anaemia, low white blood cell counts).

Taking other medicines: Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop as some medicines or foods may reduce the effectiveness of Lynparza.

Side effects: Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LYNPARZA tablets. Possible side effects include feeling or being sick (nausea or vomiting), dizziness, tiredness or weakness, indigestion or heartburn, loss of appetite, headache, change in taste of food (if it worries you), diarrhoea, sore mouth, cough, pain in the stomach area under the ribs, shortness of breath and/or a dry cough which can be due to inflammation of the lungs (pneumonitis), rash, itchy swollen reddened skin and facial swelling.

For further information on the side effect profile, contraindications, precautions and interactions please refer to the Consumer Medicine Information for Lynparza.

Lynparza Consumer Medicine Information: http://www.guildlink.com.au/gc/ws/astra/cmi.cfm?product=apclyntb10719


PBS Information: Authority Required.
Refer to PBS schedule for full information.

 

PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING. FURTHER INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA.

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: 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. Please visit astrazeneca.com.au

To find out more about Prostate Cancer Foundation of Australia, or for support, visit pcfa.org.au or call 1800 22 00 99.

ENDS

Media contact:
Laura McKoy | M. 0435 094 788

 

Refrences

  1. Pharmaceutical Benefits Advisory Committee (PBAC) Date accessed: February 2022
  2. Lynparza (olaparib) Product
  3. Cancer Prostate cancer in Australia statistics. Available at: https://canceraustralia.gov.au/affected- cancer/cancer-types/prostate-cancer/statistics. Date Accessed: February 2022
  4. Prostate Cancer Foundation of Prostate cancer in Australia – what do the numbers tell us? Available at: https://www.prostate.org.au/news-media/news/prostate-cancer-in-australia-what-do-the-numbers-tell- us/#:~:text=According%20to%20Cancer%20Australia%2C%20at,with%20prostate%20cancer%20in%20the. Date Accessed: February 2022
  5. Abida, , Armenia, J., & Gopalan, A. et al. Prospective Genomic Profiling of Prostate Cancer Across Disease States Reveals Germline and Somatic Alterations That May Affect Clinical Decision Making | JCO Precision Oncology. (2017). Available from: https://ascopubs.org/doi/10.1200/PO.17.00029. Date accessed: February 2022
  6. Powers, E., Karachaliou, G.S., Kao, C. et al. Novel therapies are changing treatment paradigms in metastatic prostate J Hematol Oncol 13, 144 (2020). Available at: https://doi.org/10.1186/s13045-020-00978-z. Date accessed: February 2022
  7. Sundararajan, , Ahmed, A., Goodman, O et al. The Relevance of BRCA Genetics to Prostate Cancer Pathogenesis and Treatment. Clin Adv in Haem & Onc 9,10 (2011). Available at: https://www.hematologyandoncology.net/files/2013/09/ho1011_Goodman1.pdf. Date accessed: February 2022
  8. Nyberg, , Frost, D., & Barrowdale, D. et. al. Prostate Cancer Risks for Male BRCA1 and BRCA2 Mutation Carriers: A Prospective Cohort Study, European Urology, 2020;77(1): 24-35. Available at: https://doi.org/10.1016/j.eururo.2019.08.025. Date accessed: February 2022
  9. Abida, Wassim et “Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration.” Journal of clinical oncology: official journal of the American Society of Clinical Oncology vol. 38,32 (2020): 3763-3772. Available at: https://dx.doi.org/10.1200%2FJCO.20.01035. Date accessed: February 2022
  1. de Bono, , Mateo, J., Fizazi, K., Saad, F., Shore, N., & Sandhu, S. et al. (2020). Olaparib for Metastatic Castration- Resistant Prostate Cancer. New England Journal Of Medicine, 382(22), 2091-2102. Available at: https://doi.org/10.1056/nejmoa1911440. Date accessed: February 2022
  1. Prostate Cancer Foundation of Advancing precision medicine for metastatic prostate cancer. Available at: https://www.prostate.org.au/news-media/news/advancing-precision-medicine-for-metastatic-prostate-cancer-us-fda- approves-new-parp-inhibitors/. Date accessed: February 2022
  2. Merseburger, , Waldron, N., Ribal, M., Heidenreich, A., Perner, S., & Fizazi, K. et al. (2021). Genomic Testing in Patients with Metastatic Castration-resistant Prostate Cancer: A Pragmatic Guide for Clinicians. European Urology, 79(4), 519-529. Available at: https://doi.org/10.1016/j.eururo.2020.12.039. Date accessed: February 2022
  3. Cancer Council What is prostate cancer? Available at: https://www.cancer.org.au/cancer-information/types- of-cancer/prostate-cancer. Date accessed: February 2022
  4. Prostate Cancer Foundation of Australia. Enzalutamide has benefits when taken after Abiraterone by men with metastatic prostate Available at: https://www.prostate.org.au/news-media/news/enzalutamide-has-benefits- when-taken-after-abiraterone-by-men-with-metastatic-prostate-cancer/. Date accessed: February 2022
  5. Ibrahim, M., Yadav, S., Ogunleye, F. et al. Male BRCA mutation carriers: clinical characteristics and cancer spectrum. BMC Cancer 18, 179 (2018). Available at: https://doi.org/10.1186/s12885-018-4098-y. Date Accessed: February 2022
  6. The Institute of Cancer Men over 40 with BRCA2 gene fault ‘should get regular PSA screening’. Available at: https://www.icr.ac.uk/news-archive/men-over-40-with-brca2-gene-fault-should-get-regular-psa-screening. Date Accessed: February 2022