WebMar 15, 2024 · Darolutamide is associated with a low rate of serum enzyme elevation during therapy, but has not been linked to cases of clinically apparent liver injury with jaundice. Darolutamide is a third generation, oral nonsteroidal antiandrogen used to treat nonmetastatic castration-resistant prostate cancer. Darolutamide is associated with a … WebAug 8, 2024 · Darolutamide in combination with docetaxel and ADT demonstrated a 32.5% reduction in the risk of death compared to docetaxel plus ADT. Overall incidence of treatment-emergent adverse events (TEAEs ...
Darolutamide in Nonmetastatic, Castration-Resistant Prostate …
WebJul 30, 2024 · Dear Dr. Mondabon, Please refer to your new drug application (NDA) dated February 26, 2024, received ... Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer.” Reference ID: 4469847: NDA 212099 Page 3: U.S. Food and Drug Administration: harrington partial hospitalization program
Approval Package for: APPLICATION NUMBER - Food and …
WebMore About Darolutamide. Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug. MedlinePlus Information on Darolutamide - A lay language summary of important information about this drug that may include the following: warnings about this drug, what this drug is used for and how it is used, WebApr 1, 2024 · Darolutamide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. You must use an effective method of birth control during treatment with this medicine and for 1 week after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away. ... Webdarolutamide. ( DAR-oh-LOO-ta-mide ) Other Name (s): Nubeqa®. Appearance: tablet. Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique ... harrington pemberton retractor