The FDA has approved Bayer nubeqa ® for the treatment of patients with adenocarcinoma

today, Bayer announced FDA approval for Nubeqa® (darolutamide) for the treatment of patients with non-metastatic desopathic prostate cancer (nmCRPC).The FDA's approval of the darolutamide listing is based on the performance of darolutamide in a Phase 3 clinical trial called ARAMIS.results showed that darolutamide combined ADT significantly improved non-transferable lifetime (MFS) (HR=0.41, 95% CI 0.34-0.50) compared to placebo combined androgen deprivation therapy (ADT); P<0.001), which means a 59% reduction in the risk of patient metastasis or death.The mid-level MFS in the Darolutamide joint ADT treatment group was 40.4 months, the placebo group was 18.4 months, and the medium MFS improved overall to 22 months. The test observed a positive trend in total survival rate (OS) (HR-0.71, 95% CI 0.50-0.99; P -0.045), all other secondary endpoints are displayed in favor of drarolutamide., Darolutamide filed for listing in Europe and Japan in March.nubeqa ®is ® an oral nonsteroidal androgen-inhibitor antagonist.was developed by Bayer in collaboration with Finnish pharmaceutical company Orion, which began in June 2014.the agreement, Bayer will have to pay most of the development costs of the drug, orion will receive sales milestone payments from Bayer. Bayer has the right to commercialize the drug globally, and Orion has the option to co-promote the product in Europe. In addition, Orion will produce the drug for the global market.
(Drug Information Network)