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
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
EBITDA before special items decreases to €4.08 billion (7.4%)
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Pharmaceuticals and Consumer Health report higher sales (Fx & portfolio adj.) and lower earnings
225Ac-PSMA-Trillium is an investigational next-generation PSMA-targeted alpha therapy with potential to treat patients with advanced metastatic prostate cancer
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