AstraZeneca PLC — Imfinzi FDA Review (BLA761069, ORIG 1, 2017)
AstraZeneca PLC · 2017 · FDA Review (openFDA) · company profile →
Report summary
This report summarizes the clinical and statistical review of AstraZeneca's Biologics License Application for durvalumab (Imfinzi) in advanced urothelial carcinoma. It details the regulatory context and Study 1108's design, focusing on efficacy endpoints like objective response rate, duration of response, progression-free survival, and overall survival, with PD-L1 expression as a key factor. The review also covers safety data, including adverse event rates, treatment discontinuations, and durvalumab-related deaths. Specific attention is given to immune-mediated adverse events, liver function abnormalities, and the incidence and management of hepatic, gastrointestinal, and neurological adverse events across different patient cohorts.
Key findings — cited to the page
| Grade 3-4 Nausea | 2 % | · p.69 |
| Grade 1-4 Fatigue | 39 % | · p.69 |
| Grade 3-4 Diarrhea | 1 % | · p.69 |
| Grade 1-4 Nausea | 15 % | · p.69 |
| Grade 1-4 Abdominal pain | 14 % | · p.69 |
| Grade 3-4 Abdominal pain | 3 % | · p.69 |
| Grade 3-4 Adverse Reactions (All Adverse Reactions) | 46 % | · p.69 |
| Grade 1-4 Diarrhea | 13 % | · p.69 |
| Grade 1-4 Constipation | 21 % | · p.69 |
| Grade 3-4 Constipation | 1 % | · p.69 |
| Grade 1-4 Adverse Reactions (All Adverse Reactions) | 96 % | · p.69 |
| Grade 3-4 Fatigue | 6 % | · p.69 |
Source: AstraZeneca PLC ↗ · 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 →