The National Institute for Health and Clinical Excellence (NICE) has issued Final Draft Guidance recommending the use of olaparib with abiraterone and prednisone or prednisolone, for patients with untreated hormone-relapsed metastatic prostate cancer without the need for confirmed BRCA1/2 gene mutation.
Olaparib (brand name Lynparza) is an oral targeted therapy drug used to treat some types of cancers and works by inhibiting proteins called PARPs, which help damaged or cancerous cells repair themselves. It has previously been shown to be effective in patients with advanced prostate cancer who have specific genetic changes in their cancer cells, significantly delaying progression.
Data previously submitted to NICE by the company behind olaparib, AstraZeneca, shows that patients with metastatic prostate cancer that had become resistant to androgen deprivation therapy who received olaparib lived without the cancer getting any bigger for an average of 7.4 months, in comparison to 3.6 months for those taking existing treatments (abiraterone or enzalutamide). Olaparib is the first PARP inhibitor to demonstrate clinically meaningful benefit when combined with abiraterone and prednisone or prednisolone to treat relapsed mCRPC, regardless of BRCA status.
It is notable that the new guidance from NICE has approved access for this patient cohort without the need for a confirmed BRCA1/2 mutation, reducing the need for testing. Results from the PROpel Phase III trial showed that olaparib in combination with abiraterone significantly improved radiographic progression-free survival (rPFS) versus abiraterone alone as a 1st-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.
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