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FDA grants Lynparza Priority Review for PROfound
FDA grants Lynparza Priority Review for PROfound.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 2849A AstraZeneca PLC 20 January 2020 \n\n20 January 2020 07:00 GMT\n \nLynparza regulatory submission granted Priority Review in the US\nfor HRR-mutated metastatic castration-resistant prostate cancer\n \nSubmission based on PROfound, the first positive Phase III trial testing\na targeted treatment in biomarker-selected prostate cancer patients\n \nAstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that a supplemental New Drug Application for Lynparza (olaparib) has been accepted and granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, who have progressed following prior treatment with a new hormonal agent.\n \nA Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.\n \nThe Priority Review by the US Food and Drug Administration (FDA) is based on results from the Phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress.\n \nResults of the PROfound trial showed Lynparza significantly reduced the risk of disease progression or death by 66% based on a hazard ratio of 0.34 (p<0.0001) vs. abiraterone or enzalutamide in patients with BRCA1/2 or ATM-mutated mCRPC, the primary endpoint of the trial.\n \nThe trial also showed that Lynparza reduced the risk of disease progression or death by 51% based on a hazard ratio of 0.49 (p<0.0001) vs. abiraterone or enzalutamide in the overall trial population of patients with HRR-mutated (HRRm) mCRPC (those with mutations in the genes for BRCA1/2, ATM, CDK12 or 11 other HRRm genes; key secondary endpoint). The safety and tolerability profile of Lynparza in the PROfound trial was in line with that observed in previous clinical trials.\n \nMetastatic castration-resistant prostate cancer\nProstate cancer is the second-most common cancer in men, with an estimated 1.3 million new cases diagnosed worldwide in 2018 and is associated with a significant mortality rate.1 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.2...