Olaparib Indications Extended

The product information has been updated for Lynparza® (olaparib) tablets to reflect its new indication. Lynparza® tablets are now also indicated as monotherapy for BRCA-mutated metastatic castration-resistant prostate cancer that has progressed following therapy with a new hormonal agent (e.g. enzalutamide or abiraterone).

Olaparib is an inhibitor of PARP (poly (ADP-ribose) polymerase), an enzyme that facilitates DNA repair. In replicating cells, PARP Inhibition can lead to double-stranded DNA breaks. Tumour cells with mutations in BRCA1 or BRCA2 cannot effectively repair these DNA breaks, leading to cell death.

The PROfound study investigated the effectiveness of olaparib in prostate cancer compared to physician’s choice of enzalutamide or abiraterone. The primary endpoint of imaging-based progression-free survival was significantly longer in the olaparib group (7.4 months) compared to the control group (3.6 months). The most common adverse events reported were anaemia, nausea, and fatigue or asthenia with olaparib and fatigue or asthenia in the control group. Adverse events of grade 3 or higher occurred more frequently in the olaparib group than the control group (51% versus 38%).

Olaparib is not currently subsidised on the Pharmaceutical Benefits Scheme (PBS) for the treatment of prostate cancer. The PBS indications are limited to high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.