The FDA granted priority review to pembrolizumab for the treatment of women with advanced cervical cancer who progressed on or after chemotherapy, according to the drug’s manufacturer.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — is indicated for the treatment of certain patients with melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, Hodgkin Lymphoma, urothelial carcinoma and gastric cancer.
The FDA based the cervical cancer priority review on data from the phase 2 global, open-label, nonrandomized KEYNOTE-158 trial, which included patients with many types of advanced solid tumors — including cervical cancer — who progressed on standard therapy.
The FDA is expected to make a decision on the new indication for pembrolizumab by June.
“Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need,” Roger Dansey, MD, senior vice president and therapeutic area head for oncology late-stage development at Merck Research Laboratories, said in a company-issued press release. “We look forward to working with the FDA on the review of this application to help bring Keytruda to previously treated patients with advanced cervical cancer.”