Tagrisso (osimertinib) has received Breakthrough Therapy Designation from FDA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.
Tagrisso is sponsored by AstraZeneca.
“Patients with early-stage EGFRm lung cancer often experience recurrence even after successful surgery and adjuvant chemotherapy, yet there are currently no approved targeted treatments to improve outcomes,” José Baselga, executive vice president of Oncology R&D said in a statement.
FDA granted the Breakthrough Therapy Designation based on data from the phase III ADAURA trial.
In the 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 endpoint. In April 2020, an independent data monitoring Committee recommended the trial to be unblinded two years early based on its determination of overwhelming efficacy.
Tagrisso is approved for the first-line treatment of patients with metastatic EGFRm NSCLC and for the treatment of metastatic EGFR T790M mutation-positive NSCLC in the U.S., Japan, China, and the EU.
