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Lynparza approved in the EU for prostate cancer
Lynparza approved in the EU for prostate cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3098E\n AstraZeneca PLC\n 05 November 2020\n \n \n \n 5 November 2020 07:10 GMT\n \n \n \n \n \n Lynparza\n \n \n approved in the EU for the treatment of BRCA-\nmutated metastatic castration-resistant prostate cancer\n \n \n \n \n \n Only PARP inhibitor to improve overall survival vs. new hormonal agent treatments in BRCA-mutated metastatic castration-resistant prostate cancer\n \n AstraZeneca and MSD's Lynparza (olaparib) has been approved in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.\n \n \n \n \n Prostate cancer is the second-most common type of cancer in men, with an estimated 1.3 million patients diagnosed worldwide in 2018.1 Approximately 12% of men with mCRPC have a BRCA mutation.2\n \n \n \n \n \n The approval by the European Commission was based on a subgroup analysis of the PROfound Phase III trial which showed Lynparza demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus \n enzalutamide or abiraterone in men with BRCA1/2 mutations.\n \n \n \n \n \n Lynparza \n is the first and only PARP inhibitor approved in the EU in biomarker-selected advanced prostate cancer. \n It follows the \n \n recommendation for approval\n \n by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.\n \n \n \n \n \n Johann de Bono, one of the principal investigators of the PROfound Phase III trial, Head of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, said: \"This approval in the EU is a landmark moment that begins a new era of precision medicine in prostate cancer. Lynparza now provides a targeted treatment option at a molecular level to patients with advanced prostate cancer who have historically poor prognosis and few treatment options.\"\n \n \n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said:\n \"Lynparza more than tripled radiographic progression-free survival and is the only PARP inhibitor to show an overall survival benefit versus certain new hormonal ...