Libtayo(TM) (cemiplimab) Receives Positive Recommendation from the pan-Canadian Oncology Drug Review Expert Review Committee for the Treatment of Metastatic Cutaneous Squamous Cell Carcinoma

    --  Cutaneous squamous cell carcinoma (CSCC) is the second most common form
        of skin cancer accounting for approximately 20% of all skin cancer cases
        in Canada.(1)

OAKVILLE, ON, Jan. 16, 2020 /CNW Telbec/ - The Melanoma Network of Canada is pleased with the pan-Canadian Oncology Drug Review (pCODR) conditional recommendation for reimbursement of Libtayo(TM) (cemiplimab) in patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.(2 )Libtayo(TM) (cemiplimab) is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 and is the first and only biologic for the treatment of advanced CSCC available in Canada.(3)

"Cemiplimab is a major step forward in the treatment of advanced cutaneous squamous cell carcinoma. Use of this agent will revolutionize treatment of this disease which previously had few therapeutic options," said Dr. Marcus Butler, Medical Oncologist, Tumor Immunotherapy Program, Princess Margaret Cancer Centre.

The positive recommendation was based on the results of the phase II EMPOWER-CSCC 1 study. pERC concluded in its report that Libtayo(TM) (cemiplimab) aligns with patient values as there is a significant burden of illness in this population and need for more effective treatment options with tolerable side effects that are associated with less pain, scarring, and disfigurement.(2)

"The CSCC patient population is often overlooked, and this pCODR recommendation for Libtayo(TM) (cemiplimab) represents great progress and hope for the future," said Annette Cyr, Chair, Melanoma Network of Canada. "CSCC is a devastating, isolating disease and we look forward to the prospect of expedited access to this much needed treatment option for both patients and clinicians."

CSCC starts in squamous cells of the skin, which are flat cells found in the outer part of the epidermis. When CSCC is found very early and only in the epidermis, it is called CSCC in situ. It is not usually life-threatening because it is an early form of CSCC. CSCC in situ may turn into invasive CSCC. This means that the cancer can grow into nearby tissue or deeper layers of the skin.(1 )If lesions are untreated, they may continue to grow, causing damage to the surrounding tissue and potentially spreading to other parts of the body.(4)

About the Melanoma Network of Canada
The Melanoma Network of Canada is a national charity that provides patient support as well as timely and accurate prevention and information resources. The Melanoma Network of Canada is the leader and voice for the melanoma and skin cancer community and assists efforts to target funding for melanoma research. Funding raised by the Melanoma Network of Canada goes directly into patient support programs, youth prevention programs as well as research. Please visit for more information.


    1. Canadian Cancer Society. Types of non-melanoma skin cancer.Available at:
       non-melanoma-skin-cancer/types-of-non-melanoma/?region=on Accessed on
       January 14, 2020.
    2. pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC)
       initial recommendation. Available at:
       C_inRec__REDACT_approvedbyChair_03Jan2020_final.pdf Accessed on January
       14, 2020.
    3. Libtayo(TM) (cemiplimab) Product Monograph, April 10, 2019. Available at: Accessed on January 14, 2020.
    4. Melanoma Network of Canada. Non-melanoma skin cancer. Available at: Accessed on January 14, 2020.

SOURCE Melanoma Network of Canada