LYNPARZA (olaparib) - metastatic castration-resistant prostate cancer

The Committee deems that the clinical benefit (CB) of LYNPARZA (olaparib) in association with abiraterone and with prednisone or with prednisolone is substantial in the MA indication extension.

In view of:

• the evidence of superiority in the PROpel phase III study of the association of olaparib + abiraterone versus placebo + abiraterone, in terms of radiographic progression-free survival (with a point estimation of an absolute difference in median rPFS of 8.2 months where HR=0.66; 95% CI [0.54; 0.81], p<0.0001);

and despite:

• the lack of evidence of superiority of the association of olaparib + abiraterone versus placebo + abiraterone on overall survival,
• an additional toxicity primarily concerning grade ≥ 3 adverse events, with 52.8% in the olaparib group and 40.4% in the placebo group,
• the risk of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), identified as a substantial potential risk in the Risk Management Plan (RMP) and in a context of treatment at an advanced stage of the disease,
• the lack of formal conclusion that can be drawn on quality of life (exploratory outcome measure),

The Committee deems that LYNPARZA (olaparib) in association with abiraterone and with prednisone or with prednisolone provides minor clinical added value (CAV IV) versus abiraterone in association with prednisone or with prednisolone for the treatment of adult metastatic castration-resistant prostate cancer (mCRPC) patients for whom chemotherapy is not clinically indicated.