Bayer gets USFDA nod for Darolutamide, Docetaxel combo to treat metastatic hormone-sensitive prostate cancer

The approval is based on positive results of the Phase III ARASENS trial that demonstrated darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel. These results were recently published in The New England Journal of Medicine. Darolutamide is approved in more than 70 markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer.

"Darolutamide plus ADT and docetaxel has shown significant benefit in overall survival and a favorable safety profile for patients with metastatic hormone-sensitive prostate cancer," said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. "This new indication for darolutamide is particularly meaningful, as it highlights its proven tolerability and provides a new option for patients."

Prostate cancer remains the second leading cancer-related cause of death among men in the U.S., with up to one-third of patients developing metastatic disease. The incidence of mHSPC has increased by 72% in the U.S. over the past 10 years. Approximately one in three patients who are diagnosed with mHSPC survive the disease five years or longer, with most eventually experiencing progression to castration-resistant prostate cancer (CRPC).

"With compelling data from the Phase III ARASENS and ARAMIS trials, darolutamide has now demonstrated significant efficacy and tolerability in mHSPC, in addition to high-risk nmCRPC, and extends benefit to a much broader population," said Christine Roth, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology SBU at Bayer. "This approval reaffirms Bayer's commitment to patients across different stages of prostate cancer, providing these eligible patients with a reliable treatment option."

"Prostate cancer is the most common cancer among men in the U.S., with chances of survival decreasing dramatically for those diagnosed with mHSPC compared to localized prostate cancer," said Charles J. Ryan, M.D., President and Chief Executive Officer, Prostate Cancer Foundation (PCF). "This approval adds a different treatment approach for mHSPC patients and their physicians to choose from."

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.