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AstraZeneca's Tagrisso (osimertinib) has been approved in the European Union (EU) for the adjuvant treatment of adult patients with early-stage (IB, II.
EU clears Tagrisso for early-stage EGFR-mutated lung cancer
28th May 2021
The European Commission (EC) has approved AstraZeneca’s (AZ) Tagrisso for the adjuvant treatment of early-stage, epidermal growth factor receptor mutated (EGFR) non-small cell lung cancer (NSCLC) following surgery.
The EC approval is based on results from the Phase III ADAURA trial, within which adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA disease, and by 80% in the overall trial population in patients with Stage IB-IIIA disease.
In addition, disease free survival (DFS) results were consistent across all prespecified groups and were observed regardless of prior adjuvant chemotherapy use.
AZ’s Tagrisso approved for EGFR-positive NSCLC in the EU
European Commission approved Tagrisso in this setting based on positive results from the ADAURA phase 3 study
AstraZeneca’s (AZ) third-generation EGFR tyrosine kinase inhibitor (TKI) Tagrisso has been approved to treat early-stage EGFR mutated non-small cell lung cancer (NSCLC) in the EU.
The European Commission has approved Tagrisso (osimertinib) in this setting based on positive results from the ADAURA phase 3 study.
In this trial, adjuvant Tagrisso treatment was found to reduce the risk of disease recurrence or death by 80% in the overall patient population, including EGFR-mutated NSCLC patients with stage IB-IIIA disease.