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Lynparza approved in the US for prostate cancer
Lynparza approved in the US for prostate cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 4537N\n AstraZeneca PLC\n 20 May 2020\n \n \n \n 20 May 2020 07:00 BST\n \n \n \n Lynparza\n \n \n approved in the US for HRR gene-mutated\nmetastatic castration-resistant prostate cancer\n \n \n \n \n \n \n \n Only PARP inhibitor to improve overall survival vs. enzalutamide or\n \n \n \n abiraterone in a biomarker-based subset of prostate cancer patients\n \n \n with BRCA1/2 or ATM mutations\n \n \n \n \n \n A\n \n pproximately 20-30% of men with metastatic castration-resistant\n \n \n \n prostate cancer have an HRR gene mutation\n \n \n AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).\n \n The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III PROfound trial, which were published in The New England Journal of Medicine.\n \n \n \n Prostate cancer is the second-most common cancer in men and despite an increase in the number of available therapies for men with mCRPC, five-year survival remains low. HRR gene mutations occur in approximately 20-30% of patients with mCRPC.\n \n Maha Hussain, one of the principal investigators of the PROfound trial and deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, said: \"Prostate cancer has lagged behind other solid tumours in the era of precision medicine. I am thrilled by the approval of Lynparza which now brings a molecularly targeted treatment to men with HRR gene-mutated metastatic castration-resistant prostate cancer in the US. The PROfound trial was an international effort and I want to thank the patients, their families, the investigators and their teams involved in making it possible.\"\n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"Today marks the first approval for Lynparza in prostate cancer. In the PROfound trial, Lynparza more than doubled the median radiographic progression-free survival and is the only PARP inhibitor to improve overall survival, versus enzalutamide or abiraterone for men with BRCA or ATM mutations. These r...