LYNPARZA (olaparib)

The clinical benefit (CB) of LYNPARZA is substantial in the MA indication.

Considering:

• the demonstrated superiority of olaparib in terms of progression-free survival assessed by the investigator compared to placebo (median not reached in the olaparib group vs 13.8 months in the placebo group; HR = 0.30; CI_95% [0.23; 0.41]; p < 0.0001), without any demonstrated superiority on overall survival following the interim analysis scheduled in the protocol,

• the absence of any formal conclusion that can be drawn based on the quality of life results,

• the safety profile of olaparib, characterised primarily by gastrointestinal and haematological events and the absence of long-term safety data in a context in which this medicinal product can be administered as long-term treatment and cases of a malignant blood disorders have been reported, the Committee considers that LYNPARZA provides a minor clinical added value (CAV IV) in the care pathway for the treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.