Approval of reimbursement for the indication: “TALZENNA (talazoparib) is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit (CB) of TALZENNA (talazoparib) is substantial to justify public funding for the extension of the marketing authorisation indication.
Clinical Added Value
minor
In view of:
the evidence of superiority in relation to enzalutamide in terms of radiological progression-free survival (rPFS), the primary outcome measure in the TALAPRO-2 phase III study; with 151/402 (37.6%) events in the talazoparib + enzalutamide group versus 191/403 (47.4%) in the placebo + enzalutamide group, HR=0.63; 95% CI [0.51 - 0.78]; p < 0.0001.
The median rPFS was not reached (95% CI [27.5; NE]) in the talazoparib + enzalutamide group and was 21.9 months (95% CI [16.6; 25.1]) in the placebo + enzalutamide group.
and despite:
the lack of evidence of superiority on overall survival in the TALAPRO-2 phase III study of the talazoparib + enzalutamide combination in relation to the placebo + enzalutamide,
an additional toxicity primarily concerning grade > 3 adverse events reported in 75.2% of the patients in the talazoparib + enzalutamide group and 45.1% of the patients in the placebo + enzalutamide group;
the risk of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), identified as a potential substantial 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 TALZENNA (talazoparib) provides minor clinical added value (CAV IV) versus enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
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