AstraZeneca’s Tagrisso given a green light in Europe

AZ’s Tagrisso was initially approved in several countries worldwide as a second-line treatment for patients with EGFR T790M mutation-positive advanced NSCLC. This April the US Food and Drug Administration approved Tagrisso for first-line use to treat EGFR-mutated non-small cell lung cancer (NSCLC), and now the EU has done the same, giving new hope to patients at this stage of the disease.
Clinical data from the Phase III FLAURA trial showed that progression free survival in patients taking Tagrisso was 18.9 months compared to 10.2 months for those receiving the standard of care, while the objective response rate was 80% and 76% respectively. More recent analysis of the data showed that the drug’s PFS benefit over EGFR tyrosine kinase inhibitors (TKIs) was sustained throughout post-progression outcomes.
Dr David Planchard, associate Professor of Medicine, Head of Thoracic Group, Gustave Roussy cancer center said: “The FLAURA trial is changing medical practice in the 1st-line treatment of EGFR-mutated NSCLC. The progression-free survival benefit seen in the trial is unprecedented for patients with an EGFR mutation, and this benefit was consistent across all subgroups including in patients with or without central nervous system metastases. Further, the preliminary overall survival data, while not statistically significant at the time of the interim analysis, is promising, with a 37 percent reduction in the risk of death.”