GlaxoSmithKline (GSK) has secured the US Food and Drug Administration (FDA) approval for Zejula (niraparib) as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
The US regulatory agency has approved the company’s supplemental New Drug Application (sNDA) for Zejula, which is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor.
Zejula has been approved with indications to treat advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in women who have a complete or partial response to the first-line platinum-based chemotherapy, regardless of biomarker status.
GSK R&D chief scientific officer and president Hal Barron said: “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.”
GSK secured FDA approval for Zejula based on data from the phase 3 PRIMA study
GSK said that the FDA approval for Zejula with new indication is based on data from the phase 3 PRIMA study, which enrolled patients with newly diagnosed advanced ovarian cancer, and an increased risk of disease progression.
The progression-free survival (PFS) initially analysed in the homologous recombination deficient (HRd) population, followed by the overall population include the primary endpoint of the in the PRIMA clinical trial.
The company said that its Zejula has improved the PFS for patients in the PRIMA study, regardless of biomarker status. The drug has reduced 57% risk of disease progression or death, compared to placebo in the HRd population and reduced 38% risk of disease progression in the overall population.
The PRIMA study demonstrated consistent safety profile for Zejula, with thrombocytopenia, anaemia and neutropenia as the most common grade 3 or higher adverse events.
PRIMA study investigator Bradley Monk said: “PRIMA was designed for patients with ovarian cancer who have a high unmet need. The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population.
“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.”
