Posted by Michael Wonder on 31 Jul 2020
Tagrisso granted breakthrough therapy designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR mutated lung cancer
30 July 2020 - Designation based on unprecedented results from the Phase III ADAURA trial where Tagrisso reduced the risk of disease recurrence or death by c. 80%.
AstraZeneca’s Tagrisso (osimertinib) has been granted breakthrough therapy designation in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
In the ADAURA trial Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the adjuvant treatment of Stage IB-IIIA EGFRm NSCLC patients, reducing the risk of disease recurrence or death by 79% (HR 0.21; 95% CI 0.16-0.28; p<0.0001) in a key secondary outcome. In April 2020, an Independent Data Monitoring Committee recommended for the trial to be unblinded two years early based on its determination of overwhelming efficacy.
