Bayer: new indication for Darolutamide in US

(CercleFinance.com) - Bayer today announced that the US FDA has approved a supplemental new drug application (sNDA) for darolutamide, in combination with docetaxel, for the treatment of patients with hormone-sensitive metastatic prostate cancer (mHSPC).


The approval is based on the positive results of a phase III trial that showed darolutamide in combination with 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.

Bayer also points out that darolutamide is approved in over 70 markets worldwide.


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