Astellas Pharma Inc.4503.T
Oncology40 cited findings · profile updated 2026-08-20
About Astellas Pharma Inc.
4503.T is an oncology research site with a focus on various cancer treatments. The company's portfolio includes drugs studied in different settings, with reported safety profiles. For instance, in the ARCHES trial, the incidence of drug-related AEs of grade ≥3 was 9.8%, compared to 6.1% for control. The incidence of all-causality AEs of grade ≥3 was 24.3%, while for control it was 25.6%. In other studies, Grade ≥3 AEs were reported as high as 78.8% and 75.4%. Specific adverse events like hypertension (Grade ≥3 TEAE) rate was 3.3%, and malignant neoplasm progression (Grade ≥3 TEAE) rate was 1%.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| Incidence of AEs of grade ≥3 (Drug-related) | 9.8 % | Astellas Pharma Inc. — Xtandi EMA EPAR variation assessment report (EM, p.97 |
| Incidence of AEs of grade ≥3 (Drug-related) for control | 6.1 % | Astellas Pharma Inc. — Xtandi EMA EPAR variation assessment report (EM, p.97 |
| Incidence of AEs of grade ≥3 (All causality) | 24.3 % | Astellas Pharma Inc. — Xtandi EMA EPAR variation assessment report (EM, p.97 |
| Incidence of AEs of grade ≥3 (All causality) for control | 25.6 % | Astellas Pharma Inc. — Xtandi EMA EPAR variation assessment report (EM, p.97 |
| Grade ≥3 AE (zolbetuximab + mFOLFOX6 or CAPOX) | 80.1 % | Astellas Pharma Inc. — Vyloy EMA EPAR public assessment report (EMEA/H, p.230 |
| Grade ≥3 AE (Placebo + mFOLFOX6 or CAPOX) | 74.0 % | Astellas Pharma Inc. — Vyloy EMA EPAR public assessment report (EMEA/H, p.230 |
Key projects
- Xtandi (oncology)
In the ARCHES trial, the incidence of drug-related AEs of grade ≥3 was 9.8%, while for the control group it was 6.1%.
- Padcev (oncology)
Infections (SOC) (Grade 3-4) were reported at 16.2% and 18.1% in different assessments.
- Vyloy (oncology)
Nausea Grade ≥ 3 with zolbetuximab + mFOLFOX6 or CAPOX was 12.6%, compared to 4.6% for Placebo + mFOLFOX6 or CAPOX.
Every figure cites its source document. Prices refresh daily, not live. Informational only — not investment advice. Explore the Oncology research library →