The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy. Xtandi was already approved in the region for metastatic hormone-sensitive prostate cancer (HSPC), non-metastatic castration-resistant prostate cancer (CRPC), and metastatic CRPC.
Phase III Data Supports EMA’s Decision
The EMA’s decision is supported by Phase III clinical trial data, which demonstrated that the addition of Xtandi to a leuprolide regimen significantly reduced the risk of metastasis or death in patients. Moreover, the safety profile of the combination treatment was found to be consistent with that of each of the components, providing confidence in the drug’s expanded use.
Implications for Prostate Cancer Treatment
This indication extension for Xtandi marks a significant advancement in the treatment options for patients with nmHSPC who have high-risk BCR and are not candidates for salvage-radiotherapy. Astellas’ Xtandi continues to play a crucial role in addressing the unmet needs of patients with various stages of prostate cancer, offering a potential new standard of care in this indication.-Fineline Info & Tech
