- EU approves darolutamide with ADT for mHSPC based on Phase III ARANOTE trial results.
- Darolutamide reduces risk of radiological progression or death by 46% in mHSPC patients.
- Already approved in over 85 countries for mHSPC and nmCRPC.
- Prostate cancer diagnoses projected to reach 2.9 million by 2040.
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EU Approval for Darolutamide
The European Commission has approved the use of darolutamide, an oral androgen receptor inhibitor, in combination with androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC). This decision is based on the positive outcomes of the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT.
Clinical Trial Insights
The ARANOTE trial provided pivotal data supporting this approval, highlighting darolutamide's efficacy in improving clinical outcomes for men with mHSPC. The trial results showed significant benefits, reinforcing the drug's established safety and tolerability profile across all approved indications.
Global Reach and Flexibility
Darolutamide, marketed as Nubeqa™, is already approved in over 85 countries for use with ADT and docetaxel in mHSPC, as well as with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC). The new approval allows its use with or without chemotherapy, offering physicians greater flexibility in tailoring treatment plans to individual patient needs.
Prostate Cancer Statistics
Prostate cancer remains a significant health challenge, being the second most common cancer and the fifth leading cause of cancer death among men worldwide. In 2022, approximately 1.5 million men were diagnosed globally, with about 397,000 deaths. In Europe alone, there were nearly 474,000 new cases and approximately 115,000 deaths. Projections indicate that prostate cancer diagnoses could rise to 2.9 million by 2040.
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