BRIEF—Tesaro extends marketable use of Zejula in Europe

East Coast-based oncology firm Tesaro has been granted EU marketing authorization for Zejula (niraparib) as monotherapy for certain adult patients with ovarian, fallopian tube, or primary peritoneal cancer.

Zejula is the first PARP inhibitor to be approved in Europe for patients regardless of BRCA mutation status.

The approval was based on clinical results showing the risk of disease progression or death was reduced by 73% in patients with germline BRCA mutations and by 55% in patients without germline BRCA mutations.