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AstraZeneca Announces Approval of Lynparza in Japan

Friday, August 25, 2023

AstraZeneca and MSD's Lynparza (olaparib) in combination with abiraterone and prednisolone has received approval in Japan for the treatment of adult patients who have BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC).

Lynparza (olaparib) is an innovative PARP inhibitor. It stands as the pioneering targeted therapy capable of disrupting the DNA damage response (DDR) specifically in cells and tumours characterised by a homologous recombination repair (HRR) deficiency. This includes cases with mutations in BRCA1 and/or BRCA2 genes or instances where deficiency is instigated by other agents like certain DNA-damaging agents (such as NHAs).

The Lynparza combination has demonstrated a notable reduction in the risk of disease progression or mortality when compared to the standard treatment protocol. This outcome underscores the crucial significance of conducting BRCA testing upon metastatic diagnosis.

The approval of this treatment regimen in Japan signifies a positive stride, offering patients the chance to access this novel therapeutic combination. It holds the potential to establish itself as the fresh benchmark in care for individuals carrying BRCA mutations.

The PROpel trial demonstrated that the combination of Lynparza (olaparib) along with abiraterone led to significant and clinically relevant improvements in outcomes for individuals with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).

Prostate cancer is highly prevalent among men in Japan and ranks as the sixth most common cause of cancer-related mortality in the area. Despite the array of available treatment modalities, the prognosis for metastatic castration-resistant prostate cancer (mCRPC) remains grim. There are limited alternatives for patients whose cancer advances subsequent to initial therapeutic interventions.

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