AstraZeneca PLC — Tagrisso EMA EPAR variation assessment report (EMEA/H/C/004124, 2016)
AstraZeneca PLC · 2016 · EMA EPAR variation assessment report · company profile →
Report summary
AstraZeneca sought a Type II variation for Tagrisso (osimertinib) to treat adult patients with locally advanced, unresectable (stage III) NSCLC with specific EGFR mutations, whose disease had not progressed after platinum-based chemoradiation therapy. This application was supported by the Phase III LAURA study (D5160C00048). The assessment report details the regulatory process, non-clinical data, and clinical aspects, including pharmacokinetics, with a focus on the LAURA study's design and analytical methods.
Key findings — cited to the page
| Procedure Number | EMEA/H/C/004124/II/0056 | Tagrisso · p.1 |
| Submission date | 9 April 2024 | Tagrisso · p.7 |
| CHMP Opinion date | 14 November 2024 | · p.8 |
| Tagrisso EU approval date | 01-Feb-2016 | Tagrisso · EU · p.10 |
| Recommended dose of osimertinib | 80 mg once daily | Tagrisso · p.10 |
| Osimertinib dose reduction | 40 mg | Tagrisso · p.15 |
| EGFR mutation rate in US NSCLC patients | 10% to 15% | United States · p.9 |
| EGFR mutation rate in European NSCLC patients | 10% | Europe · p.9 |
| EGFR mutation rate in Asian NSCLC patients | 30% to 50% | Asia · p.9 |
Source: AstraZeneca PLC ↗ · 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 →