GSK receives CHMP positive opinion recommending approval of Zejula▼(niraparib) as first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer.
GlaxoSmithKline (GSK) plc announced that 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 CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. This opinion follows the expansion of Zejula’s indication in the US with approval by the US Food and Drug Administration earlier this year.
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 PRIMA study enrolled women with newly diagnosed advanced ovarian cancer who responded to first-line treatment with platinum-based chemotherapy, a population with high unmet needs and limited treatment options.
Zejula has the potential to be the first monotherapy PARP inhibitor approved for first-line maintenance treatment following platinum response regardless of BRCA mutational status, addressing a high unmet need in ovarian cancer.
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: “Only 20% of women with ovarian cancer are currently eligible to be treated with a PARP inhibitor in the first-line maintenance setting.i Today’s positive opinion from the CHMP will give all women in response to platinum-based chemotherapy the option to receive Zejula in the maintenance setting, reinforcing our belief in the important role this innovative medicine may play in helping these patients and the physicians working to treat them.”
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