17/08/2023
What is Zejula (niraparib) for?
Zejula (niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor, indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
It is available in capsule form each containing 100mg niraparib.
How does Zejula (niraparib) work?
PARP enzymes, PARP-1 and PARP-2, play a role in DNA repair.
Niraparib, by inhibiting these enzymes, induces death in tumour cells. Niraparib has shown efficacy in both cells with or without deficiencies in the genes involved in the repair of damaged DNA, namely the BRCA genes.
Where has Zejula (niraparib) been approved?
Zejula (niraparib) was approved for the indications: recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer by:
Food and Drug Administration (FDA), USA, March 27, 2017
European Medical Agency (EMA), European Union, November 16, 2017
Health Canada, June 26, 2019
Therapeutic Goods Administration (TGA), Australia, July 1, 2019
