Bayer completes rolling submission for darolutamide in U.S.

Bayer

27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to the U.S. FDA. 

The submission, which was initiated in December 2018, is based on data from the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC) showing a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy (ADT). 

Darolutamide plus ADT has shown a favourable safety profile compared to placebo plus ADT. These data were recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco and published simultaneously in The New England Journal of Medicine.

Read Bayer press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Submission