Immunotherapy receives a positive recommendation from the Pharmaceutical Benefits Scheme for early-stage triple-negative breast cancer

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August 23, 2023 11:30 am Australia/Sydney

On 18 August 2023 KEYTRUDA (pembrolizumab) received a positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) for the treatment of early-stage triple-negative breast cancer in patients who have not received prior systemic therapy.1

This is a meaningful step towards having funded access to KEYTRUDA via the Pharmaceutical Benefits Scheme (PBS) for patients with this aggressive type of breast cancer.

Natasha Cauchi knows firsthand what it’s like to receive a triple-negative breast cancer diagnosis. At the age of 29, while holidaying with her now-husband Daniel, she noticed a small lump that rapidly grew to the size of a cricket ball within weeks. Upon her return to Australia, she was diagnosed with triple-negative breast cancer.

She believes people living with triple-negative breast cancer need to be their own advocate, speak up and get a second opinion if they feel they need to. “Don’t wait. Get yourself an appointment and if you feel no one’s listening to you, push for answers, and understand your treatment options.”

Natasha and Daniel welcomed their first child, Oliver in March this year. “I hope I remain cancer-free, but if my cancer were to return, I’d want to be able to have access to all treatment options via the PBS.”

TNBC is a particularly aggressive form of breast cancer which can grow quickly.2,3 It tends to have a poor prognosis2,4 with a higher likelihood of having already spread upon diagnosis, and a greater tendency to come back after treatment than other types of breast cancer.2

Treating TNBC can be challenging because of limited treatment options and in some patients the cancer no longer responding to chemotherapy.4

TNBC occurs more often in patients who are under 50 years of age5 and around 10-15% of all breast cancer cases are triple-negative breast cancers.2,3 An estimated 2,500 new cases of TNBC are diagnosed in Australia each year.6

Professor Fran Boyle, medical oncologist says, “We’ve seen significant improvements in treatments for women with hormone receptor breast cancer. However, when it comes to triple-negative breast cancer, it’s only recently that treatments have emerged and it’s my hope that these treatments are made available to patients through the PBS, as soon as possible.”

Dr. Jacqui Thomson, a leading expert in breast cancer clinical trials and a medical oncologist, says, “The goal for treating the cancer before surgery is to leave little to no trace of the disease at the time of the operation. I welcome the PBAC recommendation to fund access to new treatments for TNBC, that often impacts a younger demographic of patients.”

In Australia, it can take up to 442 days on average for a cancer medicine to be listed on the PBS after TGA registration.7 Sadly, some cancer patients may not have this time.

MSD Australia strongly believes that eligible patients should be able to access the medicines they need in an affordable and timely manner. We are of the view that the best way to ensure affordable and equitable medicines access is through reimbursement on the PBS.

We continue to work in partnership with the Australian Government, patient groups, clinicians, and industry to implement much needed policy reform to accelerate affordable access to medicines through the PBS – in particular, reforms that could deliver funded access via the PBS for new medicines within 90 days of TGA registration.

Indication for triple-negative breast cancer (TNBC).8 KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. KEYTRUDA (pembrolizumab), in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumours express PD-L1 (CPS ≥10) as determined by a validated test and who have not received prior chemotherapy for metastatic disease.

KEYTRUDA Minimum Consumer Medicine Information.9 KEYTRUDA contains the active ingredient pembrolizumab. KEYTRUDA is a medicine that may treat certain cancers by working with the immune system. KEYTRUDA may be given in combination with other anticancer medicines. Not everybody is suitable to have KEYTRUDA as a treatment for their cancer. Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn’s, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage. If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby. Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed. Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. Sometimes these problems can become severe or life-threatening. More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended. These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands (especially thyroid, pituitary, and adrenal glands) and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening. Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.9 Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, low levels of thyroid hormone, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma. These are not the only side effects that occur with KEYTRUDA.

For further information read the KEYTRUDA Consumer Medicine Information available at and speak to your doctor.

PBS information: KEYTRUDA (pembrolizumab) is not listed on the Pharmaceutical Benefits scheme for triple-negative breast cancer.

Copyright ©2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 1, Building A, 26 Talavera Road, Macquarie Park NSW 2113. AU-OBR-00146 Issued August 2023


  1. Australia Government. Department of Health. Pharmaceutical Benefits Scheme. Accessed August 2023.
  2. American Cancer Society. Accessed November 2022
  3. Breast Cancer Trials. Australia. Accessed November 2022
  4. Porta FM, et al. Immune Biomarkers in Triple-Negative Breast Cancer: Improving the Predictivity of Current Testing Methods. J Pers Med. 2023 Jul 23;13(7):1176. doi: 10.3390/jpm13071176. PMID: 37511789; PMCID: PMC10381494.
  5. Dolle JM, et al. Risk factors for triple-negative breast cancer in women under the age of 45 years. Cancer Epidemiol Biomarkers Prev. 2009 Apr;18(4):1157-66. doi: 10.1158/1055-9965.EPI-08-1005. Epub 2009 Mar 31. PMID: 19336554; PMCID: PMC2754710.
  6. Cancer Council Australia. A targeted approach to triple-negative breast cancer. cancer/#:~:text=Triple%2Dnegative%20breast%20cancer%20(TNBC,TNBC%20in%20Australia%20each%20year. Accessed November 2022
  7. Medicines Matter 2022. Australia’s access to medicines, 2016-2021. Medicines Australia. Accessed August 2023
  8. KEYTRUDA (pembrolizumab) Product information. Accessed August 2023
  9. KEYTRUDA (pembrolizumab) Consumer Medicine Information. Accessed August 2023