Bayer partner seeks approval for Darolutamide plus androgen deprivation therapy for metastatic hormone sensitive prostate cancer
Orion's collaboration partner Bayer 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.
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.
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.
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