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US FDA grants priority review for Tesaro's cancer drug

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US FDA grants priority review for Tesaro's cancer drug

The U.S. FDA granted a priority review to Tesaro Inc.'s new drug application for niraparib, a poly ADP-ribose polymerase inhibitor.

Niraparib is being evaluated as a potential new treatment option for patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer following response to platinum-based chemotherapy.

The application for niraparib is supported by a phase 3 study that showed that niraparib treatment significantly prolonged progression-free survival compared to placebo.

The FDA set a target action date under the Prescription Drug User Fee Act of June 30, 2017, and is not planning to hold an advisory committee meeting to discuss the application.

An expanded access program for niraparib in the U.S. is planned to open in January 2017.