[{"orgOrder":0,"company":"Orion Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orion Corporation"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ARAMIS Phase III Data to be Presented at ASCO 2020 Reveals Nubeqa Linked with Improved Overall Survival in Non-Metastatic Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orion Corporation"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Bayer AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ARASENS Trial with Darolutamide in Combination with Docetaxel and Androgen Deprivation Therapy Meets Primary Endpoint of Significantly Increasing Overall Survival in Patients with Metastatic Hormone-Sensitive Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Orion Corporation"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Bayer AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The US Food and Drug Administration (FDA) Accepts a New Supplemental Marketing Authorization Application for the Additional Indication for Darolutamide and Grants It Expedited Processing","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Orion Corporation"},{"orgOrder":0,"company":"Orion Corporation","sponsor":"Merck & Co","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208\/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FINLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Orion Corporation"}]
Find Oncology Drugs in Phase III Clinical Development in FINLAND
ODM-208/MK5684 is an investigational CYP11A1 inhibitor, which is being evaluated in combination with hormone replacement therapy under phase 3 clinical trials for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The sNDA is based on positive results from pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival for Nubeqa (darolutamide) plus androgen deprivation therapy and docetaxel in men with mHSPC compared to ADT plus docetaxel.
The ARASENS trial, Nubeqa (darolutamide) in combination with docetaxel and androgen deprivation therapy significantly increased overall survival for patients with metastatic hormone-sensitive prostate cancer.
The CHMP recommendation is based on the results of the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT.