FDA Approves Keytruda for Advanced Cervical Cancer

This is the first anti-PD-1 combination approved for patients with persistent, recurrent or metastatic cervical cancer.

The FDA has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without Roche’s Avastin (bevacizumab), for the treatment of patients with persistent, recurrent or metastatic cervical cancer.

The approval is based on the phase 3 KEYNOTE-826 trial, which found Keytruda plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without Avastin demonstrated overall survival and progression-free survival.

Additionally, more patients responded in the Keytruda arm than to chemotherapy with or without Avastin, with an objective response rate of 68%. Among patients who responded, the median duration of response was 18.0 months.

“Cervical cancer more commonly affects younger women and certain women of color in the U.S., and unfortunately, women diagnosed with persistent, recurrent or metastatic cervical cancer often have a low survival rate,” Bradley Monk, M.D., oncologist with Arizona Oncology, medical director of U.S. Oncology Research Gynecology Program and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine, said in a statement.

The FDA also converted the accelerated approval of Keytruda as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1. This accelerated approval was originally granted in June 2018.