A treatment option for Australians diagnosed with a genetically complex and sometimes difficult to treat cancer, now accessible via the PBS

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September 26, 2022 8:30 am Australia/Sydney

Around 550 eligible Australians with head and neck squamous cell carcinoma (HNSCC) could receive access to immuno-oncology therapy KEYTRUDA (pembrolizumab) as a first-line treatment option via the Pharmaceutical Benefits Scheme (PBS).1

KEYTRUDA as a first-line treatment option for certain eligible patients with HNSCC will be available via the PBS from 1 October 2022.1,2

Head and neck squamous cell carcinomas (HNSCCs) are an aggressive, genetically complex, and difficult to treat group of cancers – and in some cases a debilitating and symptomatic disease.3,4,5Approximately 50% of patients relapse after treatment in the locally advanced setting, and may require further treatment.4

Professor Michael Boyer, Chief Clinical Officer, Chris O’Brien Lifehouse says, “Head and neck cancer is a complex and sometimes difficult to treat cancer, and patients with advanced stage disease often have a poor prognosis.”

“An additional first-line treatment option could give oncologists a treatment option for patients whose disease has spread or recurred after early treatment,” he added.

Patients may require intensive treatment that is often disfiguring – leaving them with poor speech articulation, difficulties in chewing and swallowing, and cosmetic disfigurement, as well as loss of taste.3This can lead to serious psycho-social impacts including low self-esteem and a sense of isolation with patients anxious about interacting with others.6 Their caregivers can also experience high rates of psychological distress.7

Furthermore, given that HNSCC survivors can be disabled as a result of their condition and treatment and unable to return to work, the economic and societal costs associated with this type of cancer can be significant.3

Nadia Rosin, CEO, Head and Neck Cancer Australia says, “Many people haven’t even heard of head and neck cancer until they, or someone they love, is diagnosed. The reality of advanced head of neck cancer in Australia is that it is a life-altering and for some a life-limiting cancer.”

In 2021, an estimated 5,104 Australians were diagnosed with head and neck cancer and approximately 1,201 died from the disease.8,9 There are 18 different cancer sites categorised as head and neck cancers – including mouth, throat, voice box, nasal, and sinus cancers. It is not uncommon that a patient may have multiple cancers in different regions of the head and neck.9

The most common risk factors for head and neck cancer are tobacco and alcohol use. Other risk factors include human papillomavirus (HPV) status, age, and male gender.8 As their condition is often associated with avoidable behaviours such as smoking, drinking, and sexual practices, people with this cancer may experience stigma because of their diagnosis.10

TGA indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) indication: KEYTRUDA (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.2

About KEYTRUDA. KEYTRUDA contains the active ingredient pembrolizumab.11 KEYTRUDA is a medicine that may treat certain cancers by working with the immune system.11 KEYTRUDA may be given in combination with other anticancer medicines.11 Not everybody is suitable to have KEYTRUDA as a treatment for their cancer.11

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.11 If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby.11 Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA.11 Tell your health care provider if you are breastfeeding or plan to breastfeed.11

Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them.11 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.11Sometimes these problems can become severe or life- threatening.11 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.11 These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening.11 Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.11 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.11 These are not the only side effects that occur with KEYTRUDA.11

For further information read the KEYTRUDA Consumer Medicine Information available at www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 and speak to your doctor.

PBS information: KEYTRUDA for HNSCC is not currently listed on the PBS.


  1. MSD Data on file.
  2. KEYTRUDA (pembrolizumab) Product Information. www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01639-1&d=20220923172310101 Accessed September 2022
  3. Jethwa AR, Khariwala SS. Tobacco-related carcinogenesis in head and neck cancer. Cancer Metastasis Rev. 2017 Sep;36(3):411-423. doi: 10.1007/s10555-017-9689-6. PMID: 28801840; PMCID: PMC5709040.
  4. Borel C, Jung AC, Burgy M. Immunotherapy Breakthroughs in the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Cancers (Basel). 2020;12(9):2691. Published 2020 Sep 21. doi:10.3390/cancers12092691
  5. Alsahafi, E., Begg, K., Amelio, I. et al. Clinical update on head and neck cancer: molecular biology and ongoing challenges. Cell Death Dis 10, 540 (2019). doi.org/10.1038/s41419-019-1769-9
  6. Lo Nigro C, Denaro N, Merlotti A, Merlano M. Head and neck cancer: improving outcomes with a multidisciplinary approach. Cancer Manag Res. 2017 Aug 18;9:363-371. doi: 10.2147/CMAR.S115761. PMID: 28860859; PMCID: PMC5571817.
  7. Badr H, Gupta V, Sikora A, Posner M. Psychological distress in patients and caregivers over the course of radiotherapy for head and neck cancer. Oral Oncol. 2014 Oct;50(10):1005-11. doi: 10.1016/j.oraloncology.2014.07.003. Epub 2014 Aug 3. PMID: 25091150; PMCID: PMC4165786.
  8. Australian Government. Cancer Australia. Head and neck cancer in Australia statistics www.cancer.gov.au/cancer-types/head-and-neck-cancer/statistics Accessed June 2022
  9. Australian Institute of Health and Welfare. Head and neck cancers Australia. Cancer series. Number 83. www.aihw.gov.au/reports/cancer/head-neck-cancers-australia/summary Accessed June 2022
  10. Lebel, S., Castonguay, M., Mackness, G., Irish, J., Bezjak, A. and Devins, G.M. (2013), The psychosocial impact of stigma in people with head and neck or lung cancer. Psycho-Oncology, 22: 140-152. doi.org/10.1002/pon.2063
  11. KEYTRUDA (pembrolizumab) Consumer Medicine Information www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1. Accessed September 2022