New Access to Two Targeted Treatments for Australian Women with Advanced HER2-positive Breast Cancer
Australians with advanced HER2-positive breast cancer, an aggressive sub-type of the disease, now have affordable access to additional treatment options. Two targeted anticancer therapies, Perjeta® (pertuzumab) and Kadcyla® (trastuzumab emtansine), will be available to patients through the Pharmaceutical Benefits Scheme (PBS) from 1 July1-4.
Australian oncologist Professor Fran Boyle from Sydney’s Mater Hospital, has welcomed the Federal Government’s decision to make Perjeta and Kadcyla available on the PBS.
“This decision is the result of ongoing collaboration between the Australian Government, specialists, patient advocacy groups and industry,” Prof. Boyle said.
The news follows a Senate Committee inquiry into the Availability of new, innovative and specialist cancer drugs in Australia,5 which will report to Parliament in August, and which has heard evidence of ongoing delays in the PBS listing of cancer drugs, including Kadcyla and Perjeta.
“While it has taken almost two years for these therapies to be made widely available, we are thrilled that Australian women with advanced HER2-positive breast cancer will finally have the same affordable access to these cancer treatments as women in many other countries,” Prof. Boyle said1, 3,6,7.
“Breast cancer has been at the forefront of cancer research and we have been fortunate to see so many advances in the treatment of this disease. Sadly the disease still takes the lives of nearly 3,000 Australians each year, so women require ongoing access to a number of effective therapies,” added Prof. Boyle8-11.
Perjeta is approved in combination with the targeted therapy, Herceptin® (trastuzumab), and the chemotherapy, docetaxel, for the treatment of women with advanced HER2- positive breast cancer who have not received prior treatment (either anti-HER2 treatment or chemotherapy) for their advanced disease. Both Perjeta and Herceptin target the HER2 protein found on cancer cells but work in different ways to block the growth and spread of cancer cells. They may also encourage the body’s own immune cells to help destroy the cancer cells1,2.
Kadcyla combines two cancer fighting drugs in one: Herceptin and the chemotherapy drug emtansine. Kadcyla is designed to attach to HER2 proteins on the surface of cancer cells. It brings the chemotherapy with it and delivers it inside the breast cancer cells to help kill them3,4.
Breast cancer is the most common cancer affecting women. More than 14,000 Australian women are diagnosed with breast cancer each year8,15. Of those, approximately 20 per cent have HER2-positive breast cancer. The HER2-positive sub-type is an aggressive form of breast cancer9,10,16.
Further information about Perjeta and Kadcyla
Perjeta and Kadcyla safety profiles
The most common side effects of Perjeta include: diarrhoea, hair-loss and low-levels of a particular white blood cell (neutropenia)1,2. The most common side effects of Kadcyla include: fatigue and tiredness, feeling sick (nausea), vomiting, diarrhoea, stomach pain, headache, rash and cough3,4.
Additional safety information about Perjeta and Kadcyla is available in the TGAapproved Consumer Medicine Information and Product Information documents, available at www.roche-australia.com/productinfo
Patients wanting more information on treatments are encouraged to talk to their physician.
Perjeta and Kadcyla TGA – approved indications
Perjeta is indicated in combination with trastuzumab and docetaxel for patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease1.
Kadcyla, as a single agent, is indicated for the treatment of patients with HER2-positive metastatic (Stage IV) breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:
- Received prior therapy for metastatic disease, or
- Developed disease recurrence during or within six months of completing adjuvant therapy3.
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1. Perjeta Product Information. Available at: http://www.roche-australia.com/productinfo (accessed June 2015)
2. Perjeta Consumer Medicine Information. Available at: http://www.roche-australia.com/productinfo (accessed June 2015)
3. Kadcyla Product Information. Available at: http://www.roche-australia.com/productinfo (accessed June 2015)
4. Kadcyla Consumer Medicine Information. Available at: http://www.roche-australia.com/productinfo (accessed June 2015)
5. Parliament of Australia. Senate Committee: Availability of new, innovative and specialist cancer drugs in Australia. Available at: http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Cancer_Drugs/(accessed June 2015).
6. Pharmaceutical Benefits Advisory Committee Public Summary Document (PSD) November 2014 Meeting: Pertuzumab Trastuzumab Psd 11 2014. Available at: http://www.pbs.gov.au/industry/listing/elements/pbacmeetings/psd/2014-11/files/pertuzumab-trastuzumab-psd-11-2014.docx (accessed June 2015)
7. Data on File.
8. Australian Institute of Health and Welfare & Cancer Australia, Breast Cancer in Australia: An Overview, 2012, Cancer Series no.71. Available at http://www.aihw.gov.au/publication-detail/?id=10737423008 (accessed June 2015).
9. Nahta R et al. Mechanisms of Disease: Understanding Resistance to HER2-Targeted Therapy in Human Breast Cancer. Clin Prac Oncol, 2006; 3(5): 269-280.
10. Baselga, M.D, et al. Pertuzumab plus Tratuzumab plus Docetaxel for Metastatic Breast Cancer. N Engl J Med, 2012; 366: 109-19.
11. American Cancer Society. Cancer Facts and Figures 2015. Available at: http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf (accessed June 2015).
15. Australian Institute of Health and Welfare. Cancer: Breast Cancer. Available at: http://www.aihw.gov.au/cancer/breast/ (accessed June 2015).
16. Wolff A.C, et al. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for HER2 Testing in Breast Cancer. Arch Pathol Lab Med, 2007; 131: 18-43.