Astellas Pharma Inc. — Xtandi EMA EPAR variation assessment report (EMEA/H/C/002639, 2013)
Astellas Pharma Inc. · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
Astellas Pharma Inc. submitted a Type II variation for Xtandi (enzalutamide) to the EMA, seeking to expand its indication to adult men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer (nmHSPC) unsuitable for salvage radiotherapy. This application is supported by the Phase 3 EMBARK study (MDV3100-13), which evaluated enzalutamide plus leuprolide, enzalutamide monotherapy, and placebo plus leuprolide. The study's primary endpoint was metastasis-free survival (MFS). EMBARK demonstrated significant MFS improvements for both enzalutamide plus ADT and enzalutamide monotherapy compared to ADT alone. The safety profile was largely consistent with known effects, though enzalutamide monotherapy showed increased ischemic heart disease and gynecomastia. The recommended dose is 160 mg daily.
Key findings — cited to the page
| Grade ≥3 TEAEs (enza+ADT) | 46.5 % | · p.120 |
| Grade ≥3 TEAEs (placebo+ADT) | 42.7 % | · p.120 |
| Grade ≥3 TEAEs (enza-mono) | 50 % | · p.120 |
| OS events for final analysis | 271 deaths | EMBARK (MDV3100-13) · p.26 |
| Target enrolment | 1050 patients | EMBARK (MDV3100-13) · p.23 |
| Actual enrolment | 1068 patients | EMBARK (MDV3100-13) · p.23 |
| MFS events for 90% power | 142 | EMBARK (MDV3100-13) · p.22 |
| Trial Phase | 3 | EMBARK (MDV3100-13) · p.16 |
| Target hazard ratio for MFS (primary hypothesis) | 0.58 | EMBARK (MDV3100-13) · p.22 |
| Median MFS for control group (assumption) | 55 months | EMBARK (MDV3100-13) · p.22 |
| Deaths in LTFU phase (ENZA monotherapy) | 42 | EMBARK (MDV3100-13) · p.30 |
| Total deaths in LTFU phase | 129 | EMBARK (MDV3100-13) · p.30 |
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 →