Cancer therapy for eligible women with advanced cervical cancer now listed on the ARTG

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October 28, 2022 6:00 am Australia/Sydney

Eligible Australians with persistent, recurrent, or metastatic cervical cancer now have access another cancer treatment option.

Immuno-oncology therapy KEYTRUDA® (pembrolizumab) has been listed on the Australian Register of Therapeutic Goods (ARTG) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.1

Australia is a long-standing world leader in cervical cancer prevention and control with nationwide screening introduced in 1991; the adoption of the first national human papillomavirus (HPV) vaccination program in 2007; and is first country to offer self-testing swabs to all women due for their cervical cancer screening from 1 July 2022.2,3

However, despite the success of these initiatives, inequities in cervical cancer remain. Women living in remote or very remote areas, or of socioeconomic disadvantage and of younger age (25-39 years) were disproportionately affected (2007–2013).2

More than 70% of cervical occurs in women who had never screened or who were lapsed screeners.4

Mortality rates were almost 3 times higher in women in indigenous versus non-indigenous women.2

In 2021 the incidence rate for cervical cancer was estimated to increase with age, peaking at age group 40–44 years and then decreasing.5 Women diagnosed with metastatic cervical cancer face a poor prognosis with only a 17.6% 5-year survival rate.6

Dr Janine Lombard, Medical Oncology, Calvary Mater Hospital says, “Navigating a metastatic cervical cancer diagnosis can be overwhelming. From dealing with the symptoms from the cancer itself to the realisation their cancer may be incurable, patients can suffer.”

“Over the past two decades there have been very few advances in the treatment of metastatic cervical cancer. An additional treatment option we can offer patients who have been diagnosed with this disease can offer hope,” she added.

Prashant Nikam, Managing Director, MSD Australia & New Zealand says, “We are proud to be able to make KEYTRUDA available as a treatment option for eligible advanced cervical cancer patients in Australia.”

Australia is expected to be the first country to achieve WHO’s definition of cervical cancer elimination (target incidence of <4 per 100,000) as a public health problem, potentially as early as 2028.2,7 The Australian Government has also committed $5.8 million to support the aim of being the first nation in the world to eliminate cervical cancer.7

About KEYTRUDA1

Cervical cancer indication: KEYTRUDA (pembrolizumab) in combination with platinum chemotherapy and paclitaxel, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.1

KEYTRUDA contains the active ingredient pembrolizumab.8 KEYTRUDA is a medicine that may treat certain cancers by working with the immune system.8 KEYTRUDA may be given in combination with other anticancer medicines.8 Not everybody is suitable to have KEYTRUDA as a treatment for their cancer.8

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.8 If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby.8 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.8

Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them.8 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.8 Sometimes these problems can become severe or life-threatening.8 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.8 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.8 Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur.8 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, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma.8 These are not the only side effects that occur with KEYTRUDA.8

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: This product is not listed on the Pharmaceutical Benefits Scheme (PBS) for advanced cervical cancer.

References

  1. KEYTRUDA (pembrolizumab) Product Information www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01639-1&d=20220902172310101 Accessed September 2022
  2. National Health and Medical Research Council (NHMRC), 2021 Cervical Cancer Elimination report. www.cervicalcancercontrol.org.au Accessed June 2022
  3. Australian Government Department of Health. Self-collection to increase choice within the National Cervical Screening Program. www.health.gov.au/news/self-collection-to-increase-choice-within-the-national-cervical-screening-program Accessed June 2022
  4. Australian Institute of Health and Welfare (AIHW). Analysis of cervical cancer and abnormality outcomes in an era of cervical screening and HPV vaccination in Australia. Release date: 02 Sep 2019. www.aihw.gov.au/reports/cancer-screening/analysis-of-cervical-cancer-and-abnormality/summary Accessed June 2022
  5. Australian Government. Cancer Australia. Cervical cancer in Australia statistics. www.canceraustralia.gov.au/cancer-types/cervical-cancer/statistics Accessed June 2022
  6. US National Cancer Institute. The Surveillance, Epidemiology, and End Results (SEER) database website: https://seer.cancer.gov/statfacts/html/cervix.html Accessed March 2022
  7. Australian Government Department of Health. Australia backs commitment to lead the world in eliminating cervical cancer www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/australia-backs-commitment-to-lead-world-in-eliminating-cervical-cancer Accessed June 2022
  8. KEYTRUDA Consumer Medicine Information http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 Accessed September 2022