US regulators will undertake a priority review of MSD’s Keytruda as a treatment for patients with advanced cervical cancer.
The company is seeking approval for the drug’s use in patients with the condition who experience disease progression on or after chemotherapy.
The decision marks the first filing acceptance and priority review issued for an anti-PD-1 therapy in cervical cancer, and the 14th regulatory submission accepted by the FDA for Keytruda, MSD noted.
“Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need. 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,” said Dr Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
The FDA has target action date of June 28, 2018.