Bayer has announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for its oral androgen receptor inhibitor, darolutamide. The company is seeking approval for darolutamide in combination with androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide, marketed under the brand name Nubeqa™, is already approved in combination with ADT and docetaxel in over 80 markets for mHSPC, and in over 85 countries for treating non-metastatic castration-resistant prostate cancer (nmCRPC) in high-risk patients. As of September 2024, Nubeqa sales surpassed one billion euros year-to-date.
“Our goal is to redefine living with prostate cancer at various stages, extending survival and delaying progression while preserving quality of life,” said Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer. “This sNDA submission is a key step in offering physicians more options to tailor treatment plans to individual patient needs.”
The Phase III ARANOTE trial demonstrated that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in mHSPC patients. The trial showed consistent benefits across various subgroups, and the treatment-emergent adverse events (TEAEs) were minimal, reaffirming the safety profile of darolutamide seen in earlier ARAMIS and ARASENS trials. These findings were presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology.
Darolutamide is being co-developed by Bayer and Orion Corporation, a Finnish pharmaceutical company.
