AKEEGA (niraparib/abiraterone acetate) - Prostate cancer

The Committee deems that the clinical benefit (CB) of AKEEGA (niraparib/abiraterone acetate) in association with abiraterone and with prednisone or with prednisolone is sufficient to justify public funding for this MA indication.

In view of:

• the evidence of superiority in the MAGNITUDE phase III study of the niraparib/abiraterone acetate association versus placebo + abiraterone acetate, in association with prednisone in terms of radiographic progression-free survival (primary outcome measure) in the population of patients with BRCA 1/ 2 gene mutations of cohort 1 (i.e. an estimated absolute difference of median rPFS of 5.7 months where HR=0.533; 95% CI [0.361 - 0.789]; p = 0.0014);

and despite:

• the lack of evidence of superiority of the association of niraparib + AAP versus placebo + AAP on overall survival (HR=1.010; 95%CI [0.751, 1.357]; p=0.9480, NS);
• an additional toxicity primarily concerning grade ≥ 3 adverse events, with 72.2% in the niraparib + AAP group and 49.3% 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 the secondary outcome measures (TCC, TSP, OS) in the population of patients with BRCA 1/ 2 gene mutations of cohort 1 (MA population; exploratory analysis);
• the lack of formal conclusion that can be drawn on quality of life (exploratory outcome measure);

the Committee deems that AKEEGA (niraparib/abiraterone acetate) in association with prednisone or with prednisolone provides minor clinical added value (CAV IV) in relation to abiraterone in association with prednisone or with prednisolone for the treatment of adult metastatic castration-resistant prostate cancer (mCRPC) patients, with BRCA1/2 gene mutations (germline and/or somatic) and for whom chemotherapy is not clinically indicated.