U.S. FDA accepts new drug application and grants priority review for darolutamide

Bayer

29 April 2019 - Bayer today announced the U.S. FDA has accepted the new drug application and granted priority review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer.

The application and priority review status were based on data from the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer.

Darolutamide is an investigational, non-steroidal androgen receptor antagonist with a distinct chemical structure that binds with high affinity to the receptor, inhibiting the growth of prostate cancer cells.

Read Bayer press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier