Bayer: new indication for darolutamide in the USA

( – Bayer today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for darolutamide, in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The approval is based on positive results from a phase III trial which showed that 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.

Bayer also recalls that darolutamide is approved in more than 70 markets around the world, including the United States, the European Union (EU), Japan and China, under the brand name Nubeqa.

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