MSD receive FDA fast track review for Keytuda to treat cervical cancer
US regulators will conduct a priority review of MSD’s Keytruda to treat patients with advanced cervical cancer.
The company is seeking approval for the drug’s use in patients with cervical cancer who experience disease progression during or post chemotherapy.
The FDA’s 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.