ZEJULA (niraparib), PARP (poly-ADP ribose polymerase) inhibitor

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Nov 14 2018

Reason for request

Inclusion

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

-


Clinical Added Value

minor

-


-