trending Market Intelligence /marketintelligence/en/news-insights/trending/co4ftzpdGATP6g2-taAaTA2 content esgSubNav
In This List

US FDA grants priority review for Tesaro's cancer drug

Case Study

Identifying PPE Suppliers During the Pandemic

Blog

Highlighting the Top Regional Aftermarket Research Brokers by Sector Coverage

Video

COVID-19 Impact & Recovery: Healthcare Outlook for H2 2021

Blog

Corporate Credit Risk Trends in Developing Markets: A Loss Given Default (LGD) Perspective


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.