Astellas Pharma Inc. — Xtandi EMA EPAR public assessment report (EMEA/H/C/002639, 2013)
Astellas Pharma Inc. · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's CHMP positively assessed Xtandi (enzalutamide) for metastatic castration-resistant prostate cancer in adult men post-docetaxel therapy. Non-clinical studies showed enzalutamide's potent androgen receptor inhibition and potential convulsion risks. Clinical trials, including a pivotal study (CRPC2), demonstrated significant improvements in overall survival, PSA progression, and radiographic progression-free survival compared to placebo. While the safety profile is acceptable, with Grade 3+ adverse events less frequent than placebo, seizure risk is a key concern requiring post-authorization investigation. Xtandi is a strong inducer of CYP3A4 and moderate inducer of CYP2C9/2C19.
Key findings — cited to the page
| median time to first Grade >=3 event in MDV3100 arm | 12.6 months | CRPC2 (AFFIRM) · p.71 |
| Grade >=3 AEs in placebo arm | 53.1 % | CRPC2 (AFFIRM) · p.71 |
| Grade >=3 AEs in MDV3100 arm | 45.3 % | CRPC2 (AFFIRM) · p.71 |
| Grade >=3 AEs within 60 days in placebo arm | 29.6 % | CRPC2 (AFFIRM) · p.71 |
| median time to first Grade >=3 event in placebo arm | 4.2 months | CRPC2 (AFFIRM) · p.71 |
| Grade >=3 AEs within 60 days in MDV3100 arm | 20.0 % | CRPC2 (AFFIRM) · p.71 |
| Grade 3 or Higher Adverse Event in MDV3100 arm | 45.3 % | CRPC2 (AFFIRM) · p.67 |
| Grade 3 or Higher Adverse Event in placebo arm | 53.1 % | CRPC2 (AFFIRM) · p.67 |
| Grade 3 or higher AEs | 53.1 % | placebo · p.72 |
| Grade 3 or higher AEs | 46.5 % | MDV3100 · p.72 |
| Grade 4 low lymphocyte counts | 2 patients | · p.73 |
| Grade >=3 AEs in patients <= 83 kg | 49.3 % | MDV3100 · p.74 |
Source: Astellas Pharma Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →