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

This report details a Type II variation for Xtandi (enzalutamide) to expand its indication to adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). This is supported by the ARCHES and ENZAMET Phase 3 clinical trials, which demonstrated significant improvements in radiographic progression-free survival (rPFS) and overall survival (OS) with enzalutamide. The ARCHES study, designed to enroll 1,100 patients, showed a hazard ratio of 0.39 for rPFS. The report also includes updated 5-year OS results from the PREVAIL study for chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) patients. The safety profile was consistent with known effects, with common adverse events including hot flush and fatigue. Non-clinical aspects were deemed acceptable.

Key findings — cited to the page

hypertension (Grade ≥3 TEAE) rate for placebo	1.7 %	ARCHES · p.96
asthenia (Grade ≥3 TEAE) rate for placebo	0.5 %	ARCHES · p.96
Grade 3 or higher TEAEs rate	24.3 %	ARCHES · p.96
hypertension (Grade ≥3 TEAE) rate	3.3 %	ARCHES · p.96
asthenia (Grade ≥3 TEAE) rate	1 %	ARCHES · p.96
Grade ≥ 3 TEAEs	25.6 %	ARCHES · p.77
Grade ≥ 3 TEAEs	43.2 %	Phase 3 CRPC studies · p.77
Median time to first grade ≥ 3 TEAE (months)	24.9 months	Phase 3 studies · p.78
Median time to first grade ≥ 3 TEAE (months)	17.7 months	Phase 3 studies · p.78
Grade 3 or higher TEAEs rate for placebo	25.6 %	ARCHES · p.96
Grade ≥ 3 TEAEs	24.3 %	ARCHES · p.77
malignant neoplasm progression (Grade ≥3 TEAE) rate	1 %	ARCHES · p.96

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 →