GENENTECH INC — Tecentriq FDA Summary Review (NDA/BLA 761034, 2016)
Roche Holding AG · 2016 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA's review of atezolizumab (Tecentriq) for advanced urothelial bladder cancer. Efficacy data from Study GO29293 demonstrated an objective response rate of 14.8% overall, with higher rates in PD-L1 positive patients and durable responses. The safety profile revealed common adverse reactions like fatigue and decreased appetite, with 50% of patients experiencing Grade 3-4 adverse events, including immune-related events. The review also detailed specific safety findings such as pancreatitis and infections. The FDA decided against an Advisory Committee meeting for the efficacy supplement and outlined postmarketing requirements, including a Phase 3 study and submission of duration of response data.
Key findings — cited to the page
| Pyrexia (All Grades) | 21 % | · p.14 |
| All Adverse Reactions (Grades 3-4) | 50 % | · p.14 |
| Fatigue (All Grades) | 52 % | · p.14 |
| Fatigue (Grades 3-4) | 6 % | · p.14 |
| Grade 3-4 adverse events | 50% | atezolizumab · p.5 |
| All Adverse Reactions (All Grades) | 96 % | · p.14 |
| Diarrhea (Grades 3-4) | 1 % | · p.14 |
| Abdominal pain (All Grades) | 17 % | · p.14 |
| Abdominal pain (Grades 3-4) | 4 % | · p.14 |
| Vomiting (All Grades) | 17 % | · p.14 |
| Vomiting (Grades 3-4) | 1 % | · p.14 |
| Nausea (All Grades) | 25 % | · p.14 |
Source: Roche Holding AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →