Sydney, 1 November – LIBTAYO® (cemiplimab), the first immunotherapy approved in Australia for use in advanced cutaneous squamous cell carcinoma (CSCC),1 will become available on the Pharmaceutical Benefits Scheme (PBS) from 1 November 2022.2
LIBTAYO will be PBS-listed for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC), when curative surgery and curative radiation is not suitable.2
LIBTAYO, an immune checkpoint inhibitor, is a fully human immunoglobulin G4 (IgG4) monoclonal antibody. It works by binding to the programmed cell death-1 (PD-1) receptor to inhibit cancer cells from using the PD-1 pathway to suppress T-cell activation.1 This enables the body’s immune system to remain active so it can attack and kill cancer cells.1
CSCC is a common type of non-melanoma skin cancer (NMSC). CSCC and basal cell carcinoma are NMSCs and are collectively more common than melanoma.9 Approximately 1700 Australians were estimated to have died from advanced NMSC in 2020.3 This translates to up to four people per day. Additionally, NMSC can heavily impact a person’s daily life and cause significant anxiety and relationship difficulties. 10,11
Until now, no subsidised treatment options have been available specifically for Australians with advanced CSCC when curative surgery and curative radiation are not suitable. It is anticipated that approximately 1,000 Australians may be eligible for treatment each year.
Professor Danny Rischin, Medical Oncologist, Department of Medical Oncology, Peter MacCallum Cancer Centre
“Advanced CSCC can cause a great deal of distress due to severe pain, marked alteration of facial appearance, and impact on critical facial structures and function e.g., eyes, ears and nose.”
“LIBTAYO is the first reimbursed treatment option available specifically for patients for whom curative surgery and radiation is not an option or not suitable. LIBTAYO provides an alternative to surgery that could cause severe disfigurement or dysfunction, or impact on critical functions e.g., removal of an eye.”
Kasia Siwek, Head of Medical Specialty Care, Sanofi Australia & New Zealand
“Sanofi welcomes the PBS listing of LIBTAYO in advanced CSCC and is proud of our continued support for Australians impacted by this distressing and potentially life-threatening skin cancer.”
“Australian cancer specialists have played a leading role in a global CSCC clinical trial for LIBTAYO, and we are delighted that a broader group of clinicians will now be able to offer LIBTAYO to suitable patients.”
Australia is known as the ‘skin cancer capital of the world’.4,5 It is estimated that cases of non-melanoma skin cancer exceed all other cancer types combined, with Medicare data showing there were more than 1 million treatments for non-melanoma skin cancer in 2020.5
Australian Clinical Practice Guidelines recommend patients with complex mCSCC or laCSCC are referred to and assessed by a specialist or a multidisciplinary team that may include a medical oncologist, radiation oncologist, surgical oncologist, head and neck surgeon, reconstructive surgeon and dental oncologist to determine the most suitable treatment approach.6 If treatment with LIBTAYO is deemed suitable, it must be initiated and supervised by physicians experienced in the treatment of cancer.1
The efficacy and safety of LIBTAYO in patients with mCSCC or laCSCC who were not candidates for curative surgery or radiation were studied in clinical trial EMPOWER-CSCC 1 (Study 1540) – the largest (n=193) clinical dataset for a PD-1 inhibitor in advanced CSCC.1 Nearly 40% of the trial participants were Australians.1,7
Provisional approval for LIBTAYO in advanced CSCC was first granted by the Therapeutic Goods Administration in July 2020 on the basis of objective response rate (ORR) and duration of response from single arm clinical studies.1 Provisional approval is given to medicines that treat life-threatening conditions where preliminary clinical data demonstrates the medicine is likely to provide a major therapeutic advance, and clinical trials are ongoing.8
The recommended dose of LIBTAYO is 350mg every 3 weeks administered as an intravenous infusion over 30 minutes.1 Treatment may be continued until disease progression or unacceptable toxicity.1 No dose reductions are recommended, however dosing delay or discontinuation may be required based on individual safety and tolerability.1
LIBTAYO is contraindicated in patients with a hypersensitivity to cemiplimab or any of its excipients. Special warnings and precautions for use include immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, skin adverse reactions, nephritis) and infusion-related reactions.1
Full Product Information is available at
https://www.guildlink.com.au/gc/ws/sw/pi.cfm?product=swplibtayo
or by contacting Sanofi Medical Information on 1800 818 806
An animation about CSCC is available at
https://senateshj.digitalpigeon.com/msg/p7pnUFZaEe2fdgYQrKjE8w/HQ8YnxPqWpVeZ86GJOzz4Q
Minimum Product Information for Libtayo® (cemiplimab)
INDICATIONS: Cutaneous Squamous Cell Carcinoma. Provisional approval for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation. The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine. DOSAGE AND ADMINISTRATION Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. Recommended dose: 350 mg cemiplimab every 3 weeks (Q3W) administered as an intravenous infusion over 30 minutes. Treatment may be continued until disease progression or unacceptable toxicity. Dose modifications: No dose reductions are recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability. Refer to full PI. CONTRAINDICATIONS Hypersensitivity to cemiplimab or any of its excipients. PRECAUTIONS Traceability, immune-related adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, skin adverse reactions, nephritis), infusion-related reactions. Refer to full PI. Pregnancy: Pregnancy Category D. INTERACTIONS No pharmacokinetic studies have been conducted with cemiplimab. Use of systemic corticosteroids or immunosuppressants before starting cemiplimab should be avoided. ADVERSE EFFECTS Upper respiratory tract infection, urinary tract infection, anaemia, infusion-related reaction, headache, peripheral neuropathy, hypertension, decreased appetite, cough, dyspnoea, pneumonitis, nausea, diarrhoea, constipation, abdominal pain, vomiting, stomatitis, colitis, hepatitis, rash, pruritus, musculoskeletal pain, nephritis, fatigue, ASAT increase, ALAT increased, blood alkaline phosphatase increased, blood creatinine increased. Refer to full PI. NAME OF SPONSOR sanofi-aventis australia pty ltd, 12-24 Talavera Road, Macquarie Park, NSW 2113.
Based on Full Product Information with TGA date of approval of 06 September 2022. Date of Preparation: 06 September 2022.
LIBTAYO was jointly developed by Sanofi and Regeneron under a global collaboration agreement.
Issued by SenateSHJ on behalf of Sanofi.
References
- Sanofi. LIBTAYO® (cemiplimab) Approved Product Information. September 2022 Available at: https://www.guildlink.com.au/gc/ws/sw/pi.cfm?product=swplibta
Last accessed 4 October 2022).
- Additional criteria apply. Department of Health. Schedule of Pharmaceutical Benefits. Available at:
- Sanofi. 2020. The burden of non-melanoma skin cancer in Australia.[Online] Available at: https://www.sanofi.com.au/dam/jcr:c4b262a8-cae0-401a-848b-5a569026190f/NMSC%20report_18%20September%202020.pdf (last accessed 4 October 2022).
- Australian Institute of Health and Welfare. Skin cancer in Australia. Canberra, ACT: AIHW, Department of Health; 2016 Jul 13. Report No.: CAN 96. Available at: (last accessed 4 October 2022).
- Walker H, Maitland C, Tabbakh T et al. Forty years of Slip! Slop! Slap! A call to action on skin cancer prevention for Australia. Public Health Res Pract. March 2022.
- Cancer Council Australia. Clinical Guidelines. Available at: (last accessed 4 October 2022)
- Clinicaltrials.gov [Online] Available from: (last accessed 4 October 2022).
- Australian Government. Therapeutic Goods Administration. Provisional determination eligibility criteria. [Online] Available at: (last accessed 4 October 2022)
- Cancer Council Australia. 2021. Understanding skin cancer booklet. Available at: (last accessed 4 October 2022).
- Radiotis G, Czajkowska Z, & Manish Khanna MD. (2014). Nonmelanoma skin cancer: disease-specific quality-of-life concerns and distress. In Oncology nursing forum. 41(1):. 57-65. Oncology Nursing Society.
- Rhee J, Matthews B, Neuburg M, Burzynski M, & Nattinger A. (2005). Creation of a quality of life instrument for nonmelanoma skin cancer patients. Laryngoscope. 115(7), 1178–1185
sanofi-aventis australia pty ltd trading as Sanofi. ABN 31 008 558 807. Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park, NSW, 2113, AUSTRALIA. MAT-AU-2202813. Date prepared: October 2022.
About us:
About CSCC
Cutaneous squamous cell carcinoma (CSCC) is a type of non-melanoma skin cancer.9 It is far more common than melanoma and is grouped with basal cell carcinoma (BCC) under the banner of non-melanoma skin cancer.3CSCC that invades through the membrane that separates the top layer of skin (epidermis) from the next layer (called the dermis) and spreads extensively is called locally advanced CSCC.9 If left untreated, it can spread to other parts of the body.9 This is called metastatic CSCC.9 Treatment options for advanced CSCC are limited primarily to surgery and chemotherapy.6Radiation therapy may also be used in place of surgery, or with surgery.6
About Professor Danny Rischin
Professor Danny Rischin is the Director of the Division of Cancer Medicine and Head of the Department of Medical Oncology at PeterMac (Peter MacCallum Cancer Centre). He is also a consultant Medical Oncologist at the Mercy Hospital for Women and holds an academic appointment as Professor of Medicine at The University of Melbourne. In 2011 he was appointed an Associate Editor of the Journal of Clinical Oncology. Professor Rischin graduated from Monash University and completed his internal medicine and medical oncology training in Melbourne and Toronto. He was Chair of the ANZGOG RAC from 2002 till 2011 and has been an executive member of ANZGOG since its inception.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
