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Merck & Co.'s Keytruda gets US FDA priority review for advanced cervical cancer

The U.S. Food and Drug Administration granted priority review to Merck & Co. Inc.'s new supplemental biologics license application for Keytruda to treat advanced cervical cancer, the 14th accepted regulatory filing for the drug.

If approved, the anti-programmed death receptor-1, or anti-PD-1, therapy will be used to treat patients with advanced cervical cancer that progressed while undergoing or after receiving chemotherapy. Keytruda is the first medicine of its kind to receive priority review in the cervical cancer indication.

Anti-PD-1 therapies work by blocking the PD-1 pathway, allowing the immune system to destroy cancer cells.

The U.S. regulator will reach a decision by June 28.

Merck's application is supported by the results of the phase 2 Keynote-158 trial evaluating Keytruda in patients with multiple types of advanced solid tumors that progressed while receiving standard of care therapy.