(Sharecast News) - GlaxoSmithKline announced on Thursday that the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for 'Zejula', or niraparib.
The FTSE 100 pharmaceutical giant described Zejula as an oral, once-daily poly polymerase (PARP) inhibitor, 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.
It said that until now, 20% of women with ovarian cancer - those with a BRCA mutation (BRCAm) - 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%," said chief scientific officer and president of research and development Dr Hal Barron.
"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."
GSK said Zejula is the only once-daily PARP inhibitor approved in the US as 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.
It said the new indication was supported by data from the phase 3 PRIMA study, which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status.
The PRIMA study enrolled women who had higher risk of disease progression, a population with high unmet needs and limited treatment options.
"PRIMA was designed for patients with ovarian cancer who have a high unmet need," said Dr Bradley Monk, PRIMA investigator from the University of Arizona College of Medicine, Phoenix Creighton University School of Medicine at St. Joseph's Hospital Phoenix.
"The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population."
Dr Monk said the approval was 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."
The Zejula US prescribing information has been updated to include the individualised starting dose of 200 mg or 300 mg once-daily based on patients' baseline weight or platelet count for the first-line maintenance treatment indication.
GSK said the starting dose for recurrent ovarian cancer and late-line treatment settings was 300 mg once-daily.
"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, president and chief executive officer of the Ovarian Cancer Research Alliance.
"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 frontline of finding new treatments like this one to help those impacted by this disease."
At 0932 BST, shares in GlaxoSmithKline were up 0.23% at 1,680.8p.