The anti-PD-1 immunotherapy cemiplimab (Libtayo) has been provisionally registered by the TGA for adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC), who are not candidates for curative surgery or curative radiation.
According to manufacturer Sanofi Genzyme, cemiplimab is the first medicine provisionally registered for this indication in Australia, via the TGA’s pathway to fast-track access to promising new therapies for serious and life-threatening conditions.
The approval was welcomed by Professor Danny Rischin, Director of Medical Oncology at Peter MacCallum Cancer Centre, who said the therapy would represent a new standard of care for metastatic or locally advanced cutaneous squamous cell carcinoma.
“The introduction of [cemiplimab] is a critical breakthrough for a cancer that causes substantial morbidity and mortality, with a median survival of less than 15 months,” he said in a statement.
“For patients with advanced cutaneous squamous cell carcinoma who could not have curative surgery or radiation therapy, there were previously no TGA approved treatments available.”
According to the Sanofi, the approval was supported by the results from a Phase II study that included a significant number of Australian patients.