Bayer completes rolling submission for prostate cancer med

Bayer today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug darolutamide. 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).¹ These data were recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine.

“We are grateful to the patients, their families and the clinical investigators who have made this important study possible,” said Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. “The NDA submission is a key milestone bringing us closer to providing darolutamide as a potential treatment option for men with nmCRPC.”

Bayer has been granted Fast Track designation by the FDA for darolutamide in men with nmCRPC. Bayer is also in discussions with other health authorities regarding a submission of darolutamide. The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

https://www.biospace.com/article/releases/bayer-completes-rolling-submission-of-new-drug-application-to-u-s-food-and-drug-administration-for-investigational-drug-darolutamide-for-the-treatment-of-non-metastatic-castration-resistant-prostate-cancer-nmcrpc-/