September 18, 2020: “GlaxoSmithKline announced the Committee for Medicinal Products for Human Use (CHMP) of the 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.
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.
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.”
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.
Table of Contents
Ovarian Cancer
In Europe, ovarian cancer is the sixth deadliest cancer among women and more than 65,000 women are diagnosed each year.
Most women are diagnosed with advanced (stage III or IV) ovarian cancer and have a five-year survival rate of ~30%.
Despite high response rates to platinum-based chemotherapy in the first-line, approximately 85% of women with advanced ovarian cancer will see their disease return.
With each recurrence, the time a woman may spend without her cancer progressing until the next recurrence gets shorter.
Zejula (niraparib)
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials.
GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics.
The ongoing development programme for niraparib includes several combination studies.”
https://www.gsk.com/en-gb/media/press-releases/gsk-receives-chmp-positive-opinion-recommending-approval-of-zejula-niraparib-as-first-line-monotherapy-maintenance-treatment-for-women-with-platinum-responsive-advanced-ovarian-cancer/
