FDA grants priority review to Libtayo for advanced cervical cancer
Click Here to Manage Email Alerts
The FDA granted priority review to cemiplimab-rwlc for treatment of certain women with advanced cervical cancer.
The designation applies to use of the agent by women with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
Cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals, Sanofi Genzyme) is a PD-1 inhibitor. It is approved in the United States for treatment of certain patients with non-small cell lung cancer, basal cell carcinoma or cutaneous squamous cell carcinoma.
A supplemental biologics license application seeking approval for the cervical cancer indication is based on results of the randomized phase 3 EMPOWER-Cervical 1 trial, which assessed cemiplimab-rwlc monotherapy vs. investigator’s choice of chemotherapy for women with recurrent or metastatic cervical cancer whose disease progressed on platinum-based chemotherapy. Results showed a statistically significant OS benefit with cemiplimab-rwlc regardless of patients’ PD-L1 status or histology.
The FDA is expected to make a decision on the application by Jan. 30, 2022.
Read more about
Click Here to Manage Email Alerts