LYNPARZA (olaparib) - Prostate
Reason for request
Key points
Favourable opinion for reimbursement in the indication “as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent”.
What therapeutic improvement?
Therapeutic improvement compared to treatment with a new hormonal agent: abiraterone acetate or enzalutamide.
Role in the care pathway?
According to the Oncology Committee of the French Urology Association (CCAFU), the care pathway in metastatic castration-resistant prostate cancer (mCRPC) is based on new hormonal agents or “NHAs” (abiraterone acetate and enzalutamide) or taxane-based chemotherapy (docetaxel or cabazitaxel). Cabazitaxel, in combination with prednisone or prednisolone, is indicated in patients previously treated with docetaxel.
Hence the management of mCRPC in France consists in alternating the two treatment options, i.e., NHAs and chemotherapies. There is no consensus as to the optimal treatment sequence. The choice between these different therapies takes into account prior therapies, the patient’s response to these therapies, along with their general condition, age, clinical profile and preferences. For patients in whom the disease has progressed under an NHA, the treatment options remain identical to those for mCRPC in general.
The use of cabazitaxel may be of therapeutic benefit compared to an NHA in a subpopulation of patients having demonstrated rapid disease progression (<12 months) under an NHA and having previously received docetaxel.
Role of LYNPARZA (olaparib) in the care pathway:
LYNPARZA (olaparib) is a third-line treatment for patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy with enzalutamide or abiraterone acetate. In the absence of available data, its role compared to docetaxel or cabazitaxel is not known.
Clinical Benefit
Substantial |
The Committee deems that the clinical benefit of LYNPARZA (olaparib) is substantial in this indication. |
Clinical Added Value
minor |
Considering, on the one hand:
and, on the other hand:
the Committee considers that LYNPARZA (olaparib) provides a minor clinical added value (CAV IV) compared to hormone therapy with abiraterone acetate of enzalutamide, in the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
|