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Lynparza approved in US for BRCAm prostate cancer
Lynparza approved in US for BRCAm prostate cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n1 June 2023\n \nLynparza plus abiraterone approved in the US for the treatment of\nBRCA-mutated metastatic castration-resistant prostate cancer\n \nLynparza combination reduced the risk of disease progression or death by 76% vs. abiraterone alone\n \nFirst PARP inhibitor approved in combination with a new hormonal agent underscores clinically meaningful benefit of new treatment approach\n \nAstraZeneca and MSD's Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).\n \nThis approval was based on a subgroup analysis of the Phase III PROpel trial which showed that Lynparza plus abiraterone demonstrated highly clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR of 0.24, 95% CI, 0.12-0.45) and overall survival (OS) (HR of 0.30, 95% CI, 0.15-0.59) versus abiraterone alone in patients with BRCA mutations.1 Median rPFS and median OS were not reached for patients treated with Lynparza plus abiraterone versus a median of 8 months and 23 months, respectively, for those treated with abiraterone alone.\n \nProstate cancer is the second-most common cancer in men and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low.2,3 Approximately 10% of patients with mCRPC have BRCA mutations, which is associated with poor prognosis and outcomes.4,5\n \nAndrew Armstrong, MD, ScM, of the Duke Cancer Institute, Durham, North Carolina, US, and an investigator in the trial, said: \"Preventing or delaying radiographic progression or death is an important clinical endpoint in assessing cancer treatment and is very important to patients, their caregivers and their families. The PROpel results showed the Lynparza combination demonstrated a notable clinically meaningful benefit that should rapidly be considered as the standard of care treatment for patients with BRCA-mutated metastatic castration-resistant prostate cancer.\"\n \nDave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: \"There is a critical unmet need for new first-line treatment options for patients with BRCA-muta...