Astellas Pharma Inc. — Vyloy EMA EPAR public assessment report (EMEA/H/C/005868, 2024)
Astellas Pharma Inc. · 2024 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report details the assessment of Vyloy (zolbetuximab) for first-line treatment of HER2-negative, CLDN18.2-positive gastric or gastro-oesophageal junction adenocarcinoma. It covers manufacturing, quality control, and non-clinical aspects, including zolbetuximab's mechanism of action and anti-tumor activity. Preclinical studies showed efficacy in combination with chemotherapy. Clinical studies (SPOTLIGHT, GLOW) demonstrated significant improvements in progression-free and overall survival. Pharmacokinetic analyses informed dosing, while safety data highlighted gastrointestinal toxicities, particularly nausea and vomiting. Despite these, a positive benefit-risk assessment led to approval.
Key findings — cited to the page
| Nausea Grade ≥ 3 (zolbetuximab + mFOLFOX6 or CAPOX) | 12.6 % | · p.230 |
| Nausea Grade ≥ 3 (Placebo + mFOLFOX6 or CAPOX) | 4.6 % | · p.230 |
| Grade ≥3 AE (zolbetuximab + mFOLFOX6 or CAPOX) | 80.1 % | · p.230 |
| Grade ≥3 AE (Z/P related) (Placebo + mFOLFOX6 or CAPOX) | 29.2 % | · p.230 |
| Vomiting Grade ≥ 3 (zolbetuximab + mFOLFOX6 or CAPOX) | 14.3 % | · p.230 |
| Vomiting Grade ≥ 3 (Placebo + mFOLFOX6 or CAPOX) | 4.7 % | · p.230 |
| predicted probability of Grade 3 AEs at upper end of Cmax_1st distribution | less than 40 % | · p.73 |
| predicted probability of Grade 3 AEs at 50th percentile of Cmax_1st | 20 % | · p.73 |
| Grade ≥3 AE (Placebo + mFOLFOX6 or CAPOX) | 74.0 % | · p.230 |
| Grade ≥3 AE (Z/P related) (zolbetuximab + mFOLFOX6 or CAPOX) | 46.3 % | · p.230 |
| TEAE with CTCAE Grade ≥ 3 | 403 n | SPOTLIGHT/GLOW · p.59 |
| TEAE with CTCAE Grade ≥ 3 | 24 n | SPOTLIGHT/GLOW · p.59 |
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 →