ASTRAZENECA — Tagrisso FDA Summary Review (NDA/BLA 208065, 2015)
AstraZeneca PLC · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA's summary review of Tagrisso (osimertinib) for metastatic NSCLC details its accelerated approval based on tumor response. The report highlights an objective response rate of 51% and a median duration of response of 12.4 months in a specific patient subgroup. Key safety concerns include interstitial lung disease, cardiomyopathy, and QTc prolongation, with specific incidence rates for fatal events and other adverse reactions. The document also outlines post-marketing requirements and commitments for further studies to characterize the drug's effects.
Key findings — cited to the page
| Median duration of response | 12.4 months | AURA trial (dose-escalation/dose expansion cohort) · p.4 |
| Fatal cardiomyopathy | 0.2 % | · p.4 |
| Application Number | 208065Orig1s000 | · p.1 |
| Objective response rate (ORR) | 51 % | AURA trial (dose-escalation/dose expansion cohort) · p.4 |
| Confirmed ORR for AZD9291 in EGFR T790M mutation-positive patients | 61 % | AURA2 trial · p.8 |
| Fatal ILD | 0.5 % | · p.4 |
| Number of patients enrolled | 411 patients | AURA Extension and AURA2 trials · p.4 |
| Osimertinib dose | 80 mg once daily | AURA Extension and AURA2 trials · p.4 |
| Confirmed overall response rate (ORR) | 59 % | AURA Extension and AURA2 trials · p.4 |
| Responders with ongoing responses | 96 % | AURA Extension and AURA2 trials · p.4 |
| Overall response rate for docetaxel in NSCLC | 5.5 % | · p.6 |
| Patients exposed to osimertinib for at least 6 months | 333 patients | AURA Extension and AURA2 · p.4 |
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 →