(March 28, 2017) The U.S. Food and Drug Administration approved niraparib (ZEJULA, TESARO, Inc.), poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
Niraparib is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. TESARO anticipates launching niraparib in the United States in late April.