ZEJULA (niraparib), PARP (poly-ADP ribose polymerase) inhibitor
Reason for request
High clinical benefit and minor clinical added value over placebo in the maintenance treatment of patients with recurrent and platinum-sensitive high-grade serous epithelial cancer of the ovaries, fallopian tubes or primary peritoneal cancer and who are responding (complete or partial response) to platinum-based chemotherapy.
ZEJULA has been granted marketing authorisation for the maintenance treatment of patients with recurrent and platinum-sensitive high-grade serous epithelial cancer of the ovaries, fallopian tubes or primary peritoneal cancer and who are responding (complete or partial response) to platinum-based chemotherapy.
Its superiority over placebo has been established.
It is a second-line and later maintenance treatment, irrespective of BRCA mutation status.
Clinical Benefit
Substantial |
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Clinical Added Value
minor |
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