Tagrisso(osimertinib)
Oncology· 847 cited findings· 3 source documents
Company: AstraZeneca PLC →
What the regulatory reviews say
Tagrisso (osimertinib, also known as AZD9291) is a new molecular entity (NME) approved under NDA 208065 via a 505(b)(1) application. It is indicated for EGFRm+/T790M+ non-small cell lung cancer (NSCLC). The pivotal studies included AURA/AURA Extension (D5160C00001), a Phase I/II trial with a sample size of 252 patients across 5 cohorts.
Key efficacy findings include objective response rates ranging from 50.8% to 61.0%, with a duration of response of 12.4 months. The median progression-free survival was observed to be 9 to 14 months. For advanced NSCLC, median survival with supportive care is 3 to 6 months. The median best percent tumor decrease from baseline was 44.6%.
Notable safety findings include diarrhea incidence at 42% and rash incidence at 42%. Interstitial lung disease (ILD) occurred in 2.7% of patients, with 4 deaths attributed to ILD. Fatal ILD was observed in 0.5% of patients, and fatal cardiomyopathy in 0.2%.
Key figures — cited to the source page
| Objective response rate | 57.2% | AstraZeneca PLC — Tagrisso FDA Review, p.17 |
| Duration of response | 12.4 months | AstraZeneca PLC — Tagrisso FDA Review, p.17 |
| Median progression-free survival | 9 to 14 months | AstraZeneca PLC — Tagrisso FDA Review, p.18 |
| Median survival with supportive care for advanced NSCLC | 3 to 6 months | AstraZeneca PLC — Tagrisso FDA Review, p.21 |
| Diarrhea incidence | 42% | AstraZeneca PLC — Tagrisso FDA Review, p.17 |
| Interstitial lung disease incidence | 2.7% | AstraZeneca PLC — Tagrisso FDA Review, p.17 |
| Deaths due to interstitial lung disease | 4 | AstraZeneca PLC — Tagrisso FDA Review, p.17 |
| NDA/BLA Number | NDA 208065 | AstraZeneca PLC — Tagrisso FDA Review, p.131 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.