On January 7, 2025 Orion’s collaboration partner Bayer reported it has submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the oral androgen receptor inhibitor (ARi) darolutamide (Press release, Orion, JAN 7, 2025, View Source [SID1234649443]). Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The submission is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets around the world, including China. The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world, including China. Darolutamide is developed jointly by Orion and Bayer.