Despite the strong results, investigators cautioned that the study has limitations, including its open-label Phase II design, lack of randomization, and reliance on a historical external control arm
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
Darolutamide is developed jointly by Bayer and Orion Corporation
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
Net income more than doubled to 2.763 billion euros, while core earnings per share climbed 12.9 percent to 2.71 euros
The Pharmaceuticals portfolio and pipeline are more promising than perhaps ever before
Prostate cancer is one of the fastest-growing cancers in India, with approximately 37,948 new cases each year
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
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