Roche Holding AG — Tecentriq EMA EPAR public assessment report (EMEA/H/C/004143, 2017)
Roche Holding AG · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This EMA EPAR summarizes the marketing authorization for Tecentriq (atezolizumab) for advanced urothelial carcinoma and NSCLC after chemotherapy. The report details the regulatory process, product information, and manufacturing of this Fc-engineered, humanized IgG1 anti-PD-L1 monoclonal antibody produced in CHO cells. Non-clinical studies confirm its PD-L1 binding and blocking activity. Clinical data from OAK, POPLAR, IMvigor 210, and 211 studies demonstrate improved overall survival and response rates compared to chemotherapy. Tecentriq exhibits a generally favorable safety profile, though immune-related adverse events are a key risk. The report outlines the safety profile, including adverse events and serious adverse events across patient populations, and details the risk management plan and ongoing pharmacovigilance studies.
Key findings — cited to the page
| patients with at least one AE of any grade | 95.4 % | · p.153 |
| patients with Grade 1 or 2 AEs | 49.1 % | · p.153 |
| Grade 3 or 4 AEs (atezolizumab) | 40.1 % | POPLAR · p.166 |
| AESIs of any Grade (atezolizumab) | 28.9 % | POPLAR · p.166 |
| treatment-related Grade 3 or 4 AEs (atezolizumab) | 11.3 % | POPLAR · p.166 |
| treatment-related Grade 5 AEs (atezolizumab) | 0.7 % | POPLAR · p.166 |
| Grade 5 AEs (docetaxel) | 3.7 % | POPLAR · p.166 |
| treatment-related Grade 3 or 4 AEs (docetaxel) | 38.6 % | POPLAR · p.166 |
| Grade 5 AEs (atezolizumab) | 4.2 % | POPLAR · p.166 |
| AESIs of any Grade (docetaxel) | 29.6 % | POPLAR · p.166 |
| treatment-related Grade 5 AEs (docetaxel) | 2.2 % | POPLAR · p.166 |
| patients with Grade 3 or 4 AEs | 43.9 % | · p.153 |
Source: Roche Holding AG ↗ · 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 →