Niraparib (Zejula) is accepted for use within NHSScotland...as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III or IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

ZEJULA (niraparib) is now approved in Canada for the monotherapy maintenance treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

...Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has approved its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated:...for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

Niraparib is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment for advanced (FIGO stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after response to first-line platinum-based chemotherapy in adults.

...the NCCN panel recommends niraparib as maintenance therapy for patients with platinum-sensitive disease who have had 2 or more lines of platinum-based therapy...

In a real-world setting, niraparib maintenance treatment in patients with non-gBRCA1/2 mutated recurrent platinum-sensitive ovarian cancer showed effectiveness comparable with published phase III studies and acceptable safety.

This randomized clinical trial found that niraparib maintenance therapy prolonged PFS in patients with newly diagnosed aOC regardless of postoperative residual disease or biomarker status. The ISD was effective and safe in the first-line maintenance setting.

Niraparib maintained clinically significant improvements in PFS with 3.5years of follow-up in patients with newly diagnosed advanced ovarian cancer at high risk of progression irrespective of HRD status.

Zai Lab Limited...presented data from the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy at the Society of Gynecologic Oncology annual meeting. ZEJULA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a tolerable safety profile in Chinese patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status.

GlaxoSmithKline (GSK) plc today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Zejula (niraparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status....The Type II variation application is based on data from the phase 3 PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated a clinically meaningful progression-free survival benefit of Zejula treatment in the first-line maintenance setting.

...the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001)….Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency.