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Update on US review of Lynparza PROpel sNDA
Update on US review of Lynparza PROpel sNDA.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 15 December 2022 07:00 GMT\n \n \n \n \n \n \n Update on US regulatory priority review of Lynparza in combination with\n \n \n \n \n abiraterone in metastatic castration-resistant prostate cancer\n \n \n \n \n \n \n \n \n AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) dateby three months to provide further time for a full review ofthe supplementary new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment ofmetastatic castration-resistant prostate cancer (mCRPC). The companies will continue to work with the FDA to facilitate the completion of the agency's review.\n \n \n \n \n \n The sNDA is based on results from thepivotal\n \n \n PROpel Phase III trial,\n \n \n which were published in June 2022 in\n \n \n NEJM Evidence.\n \n \n In August 2022, the sNDA was granted\n \n \n Priority Review\n \n \n and AstraZeneca and MSD are committed to working with the FDA to bring this treatment option to patients with mCRPC.\n \n \n \n \n \n In\n November, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a\n \n \n positive opinion\n \n \n recommending approval of\n \n Lynparza\n \n \n in combination with abiraterone and prednisone or prednisolone in the EU for the treatment of adult patients with mCRPC for whom chemotherapy is not clinically indicated. This combination is also undergoing regulatory reviews in other countries.\n \n \n \n \n \n \n \n \n Lynparza\n \n is approved in the US based on results from the\n \n \n PROfound Phase III trial\n \n \n as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations)\n who have progressed following prior treatment with enzalutamide or abiraterone; and in the EU, Japan, and China for patients with BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent.\n \n \n \n \n \n \n Notes\n \n \n \n \n \n \n \n Metastatic castration-resistant prostate cancer\n \n \n \n Metastatic prostate cancer is associated with a significant mortality rate.11 Development of prostate cancer is often driven by male sex hormones...