FDA Accepts Application for Libtayo for Advanced Cervical Cancer

The PDUFA target action date for the FDA decision is Jan. 30, 2022.

The FDA has accepted for priority review Regeneron Pharmaceuticals’ supplemental biologics license application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The target action date for the FDA decision is Jan. 30, 2022.

The sBLA is also being reviewed under the FDA’s Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada, and Switzerland. Additional global regulatory submissions are planned, including in the European Union by the end of 2021.

The sBLA is supported by results from a phase 3 trial that enrolled patients irrespective of

PD-L1 expression status and is being conducted with The GOG Foundation, the European Network for Gynaecological Oncological Trial groups, and NRG Oncology-Japan. Results were first presented as part of a European Society for Medical Oncology (ESMO) Virtual Plenary in May 2021.

In 2018, there were an estimated 293,394 women living with cervical cancer in the United States. The National Institutes of Health predicts there will be an additional 14,480 cases this year and an estimated 4,290 deaths from cervical cancer.

Almost all cases are caused by human papillomavirus (HPV) infection, with about 80% classified as squamous cell carcinoma (SCC) and the remainder being largely adenocarcinomas. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.

Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. It is approved for several cancers, including cutaneous squamous cell carcinoma, basal cell carcinoma, metastatic basal cell carcinoma, and nonsmall cell lung cancer.