FDA approves new indication for GlaxoSmithKline’s Zejula

Women with certain types of advanced ovarian cancer have a new treatment option. The Food and Drug Administration has cleared a new indication for GlaxoSmithKline’s Zejula (niraparib).

Zejula is an oral, once-daily ADP-ribose polymerase inhibitor used as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.

Until now, only 20% of women with ovarian cancer, those with a BRCA mutation, were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.

"Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress," said Hal Barron, GSK chief scientific officer and president of research and development. 

Zejula is the only once-daily PARP inhibitor approved in the United States as a monotherapy for women with advanced ovarian cancer beyond those with BRCAm disease in the first-line and recurrent maintenance treatment settings, as well as late-line primary treatment settings.

"This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance," said Bradley Monk, PRIMA investigator, US Oncology, University of Arizona College of Medicine, Phoenix Creighton University School of Medicine at St. Joseph's Hospital Phoenix.

"It's so important for patients with ovarian cancer to have treatment options, and this approval is positive news for our community," said Audra Moran, Ovarian Cancer Research Alliance president and CEO. "PARP inhibitors represent a major advancement in the fight against ovarian cancer, and having a new first-line maintenance option for platinum-responsive advanced ovarian cancer patients — regardless of BRCA mutation status — is especially exciting. We are determined to keep funding research and partnering with scientists who are on the front line of finding new treatments like this one to help those impacted by this disease."