Tesaro begins niraparib submission

Tesaro Inc. (NASDAQ:TSRO) said it began rolling submission of an NDA to FDA for niraparib ( MK-4827) to treat recurrent, platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer. It expects to complete the submission next quarter.

Also on Monday, Tesaro said FDA granted Fast Track designation to the oral PARP inhibitor. In June, niraparib met the primary endpoint of the Phase III NOVA trial, improving progression-free survival vs. placebo in patients with and without germline BRCA mutations (see BioCentury, July 11). ...