QUADRA Phase 2 trial

October 25, 2019

FDA Approves Zejula as Late-Line Treatment for Recurrent Ovarian Cancer Patients

News

The U.S. Food and Drug Administration (FDA) has approved Zejula (niraparib) as a late-line treatment for women with advanced ovarian, fallopian tube, or primary peritoneal cancer who have tumors defective in DNA ... Read more

June 26, 2019

FDA Grants Priority Review to GSK’s Zejula for Late Stage Ovarian Cancer

News

The U.S. Food and Drug Administration (FDA) has accepted the application of Tesaro, a GSK company, seeking to extend approval for Zejula (niraparib) to women with late stage ovarian cancer ... Read more

April 30, 2018

Zejula Shows Ability to Treat Range of Advanced Ovarian Cancers in Phase 2 Trial

News

Zejula (niraparib) showed an ability to treat people with recurrent and heavily treated ovarian cancer, particularly those with mutations in DNA repairing genes, results of a Phase 2 trial show. Tesaro’s ... Read more

September 19, 2016

FDA Grants Fast Track Status to Tesaro’s Niraparib for Ovarian, Other Cancers

News

Tesaro has received fast track designation from the U.S. Food and Drug Administration (FDA) for the use of niraparib in patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. ... Read more