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(Alliance News) - GlaxoSmithKline PLC on Friday reported that a European Medicines Agency committee has adopted a positive opinion on its cancer drug Zejula.
The Committee for Medicinal Products for Human Use recommendation is for approving Zejula, the brand name for niraparib, as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy.
Glaxo's type 2 variation application is based on data from its phase 3 Prima study which demonstrated a clinically meaningful progression-free survival benefit for patients treated with Zejula in the first-line maintenance setting.
Prima enrolled women with newly diagnosed ovarian cancer who responded to first-line treatment with platinum-based chemotherapy, a group with limited options for treatment. Zejula would be the first monotherapy PARP inhibitor approved for first-line maintenance treatment following platinum response regardless of BRCA mutational status.
PARP is an enzyme in cells that helps to repair damaged DNA, and so inhibiting this enzyme prevents cancer cells from repairing themselves.
Axel Hoos, senior vice president and head of Oncology R&D at Glaxo, 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."
CHMP opinion is among the final steps in obtaining marketing authorisation before European Commission approval.
Shares in Glaxo were up 0.5% at 1,528.60 pence in London on Friday afternoon.
By Anna Farley; annafarley@alliancenews.com
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