ZEJULA (niraparib (tosilate de) monohydrate)

Key points

Favourable opinion for reimbursement as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

What therapeutic improvement?

Therapeutic improvement in the management of the disease.

Role in the care pathway?

Following initial diagnostic and excision surgery, the standard first-line systemic chemotherapy for advanced stages (FIGO stages II to IV) is a combination of platinum and taxane (usually carboplatin and paclitaxel). Despite optimal initial surgery and the administration of paclitaxel-carboplatin chemotherapy, around 70% of patients will relapse within the first three years. For these women, the 5-year survival is estimated to be 30%.

The ESMO 2019 European guidelines and the NCCN 2020 American guidelines recommend the use of an anti-VEGF therapy, AVASTIN (bevacizumab), regardless of BRCA status, in combination with chemotherapy in patients with a poor prognosis (FIGO stage IV, sub-optimal surgery, large tumour mass, etc.). Maintenance therapy with an anti-VEGF alone may then be administered when this was initially prescribed. This treatment is administered for a maximum period of 15 months or until disease progression.

In the event of BRCA 1/2 mutation (germinal and/or somatic), maintenance treatment with olaparib is recommended.

Role of ZEJULA (niraparib) in the care pathway:

ZEJULA is a first-line maintenance treatment option for advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer in partial or complete response following first-line platinum-based chemotherapy.

In the absence of comparative data versus the management strategy incorporating bevacizumab in combination with chemotherapy then continued as maintenance therapy, its role compared to maintenance treatment with bevacizumab is not known. In addition, in the absence of comparative data, the role of niraparib compared to olaparib cannot be specified in the event of a BRCA 1/2 mutation.

In addition, the MA proposed two dosage regimens (200 mg per day or 300 mg per day) depending on weight (< or ≥ 77 kg) and platelet level (< or ≥ 150,000/μL); to date, no randomised studies having compared the efficacy of these two dosages in this indication are available.