International work-sharing Initiative - Niraparib (Zejula®)

The Therapeutic Goods Administration (TGA) has approved a new drug for the treatment of some ovarian, fallopian tube, or peritoneal cancers, through an international work sharing initiative.

Niraparib (Zejula®) is the third medicine to be registered on the Australian Register of Therapeutic Goods (ARTG) that has been evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's New Chemical Entities Work Sharing Initiative. The ACSS is one of multiple initiatives in which TGA has engaged to meet the needs of the Australian people and provide improved access to the most recent and innovative treatment options.

The ACSS international collaboration initiative incentivises new drug submissions by reducing regulatory burden leading to better access to new treatments for the Australian people.

Efficiencies are achieved through the work-sharing of the evaluation, with each regulator taking a lead in the evaluation of different parts of the regulatory submission dossier. However, each regulator makes independent decisions regarding approval (market authorisation) of the new medicine.

Quick facts

• Ovarian cancer is the leading cause of death from gynaecologic cancers worldwide
• Epithelial ovarian carcinoma accounts for approximately 90% of ovarian malignancies. Primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) resemble epithelial ovarian carcinoma morphologically and clinically, and are often included within the ovarian epithelial cancer designation.
• Niraparib works by inhibiting the poly (ADP-ribose) polymerase (PARP) enzymes, which play a role in DNA repair and cell death.
• By interfering with these pathways, tumour cells can be killed, or made more susceptible to chemotherapy.