CHMP recommends approval of Zejula for ovarian cancer.- GlaxoSmithKline

GlaxoSmithKline 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 III 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.