AstraZeneca PLC — Tagrisso FDA Review (NDA208065, ORIG 1, 2015)
AstraZeneca PLC · 2015 · FDA Review (openFDA) · company profile →
Report summary
The FDA reviewed AstraZeneca's osimertinib (Tagrisso) for metastatic, EGFR T790M mutation-positive NSCLC, granting it Fast Track and Breakthrough Therapy designations. Based on efficacy data from the single-arm AURA Extension and AURA2 trials, showing high objective response rates and an acceptable safety profile, accelerated approval was recommended due to unmet medical need. The review detailed trial designs, efficacy results (including subgroup analyses), and comprehensive safety findings, covering adverse events, dose modifications, deaths, and specific concerns like ILD/pneumonitis and QT prolongation. Demographic analyses of adverse events were also included, alongside postmarketing requirements for confirmatory studies. The submission was deemed complete and organized.
Key findings — cited to the page
| Nausea (all grades) | 16.79 % | AURA Extension and AURA2 · p.96 |
| Decreased appetite (Grade 3-4) | 0.73 % | AURA Extension and AURA2 · p.96 |
| Rash (grouped terms, all grades) | 41.85 % | AURA Extension and AURA2 · p.96 |
| Nail toxicity (grouped terms, all grades) | 25.79 % | AURA Extension and AURA2 · p.96 |
| Nausea (Grade 3-4) | 0.49 % | AURA Extension and AURA2 · p.96 |
| Decreased appetite (all grades) | 15.82 % | AURA Extension and AURA2 · p.96 |
| Diarrhoea (all grades) | 42.34 % | AURA Extension and AURA2 · p.96 |
| Diarrhoea (Grade 3-4) | 0.97 % | AURA Extension and AURA2 · p.96 |
| Rash (grouped terms, Grade 3-4) | 0.49 % | AURA Extension and AURA2 · p.96 |
| Dry skin (grouped terms, all grades) | 35.5 % | AURA Extension and AURA2 · p.96 |
| All grade shifts in Creatinine | 8 % | AURA Extension and AURA2 · p.101 |
| Constipation (all grades) | 15.09 % | AURA Extension and AURA2 · p.96 |
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 →