FDA News

FDA grants Keytruda priority review for advanced cervical cancer

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.”

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.”