Posted by Michael Wonder on 03 May 2022
U.S. FDA accepts supplemental new drug application and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer
3 May 2022 - Application is being reviewed concurrently among participating international health authorities under the FDA Oncology Center of Excellence’s Project Orbis initiative
Bayer today announced the U.S. FDA has accepted a supplemental new drug application and granted priority review for the oral androgen receptor inhibitor darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer.
