EU approves first-line use of AZ’ Tagrisso in lung cancer

The decision, which significantly expands the drug’s reach in the EU, was based on clinical data from the Phase III FLAURA trial, showing that progression free survival in patients taking Tagrisso (osimertinib) was 18.9 months compared to 10.2 months for those receiving the standard of care, while the objective response rate was 80 percent versus 76 percent, respectively.

A further recent analysis of FLAURA results - presented at the European Lung Cancer Conference (ELCC) in Geneva - also showed that the drug’s PFS benefit over EGFR tyrosine kinase inhibitors (TKIs) was sustained throughout post-progression outcomes.

"The FLAURA trial is changing medical practice in the 1st-line treatment of EGFR-mutated NSCLC," said Dr David Planchard, associate Professor of Medicine, Head of Thoracic Group, Gustave Roussy cancer center, France.

"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."

Tagrisso was initially approved in several countries around the globe as a second-line treatment for patients with EGFR T790M mutation-positive advanced NSCLC.

The US Food and Drug Administration also cleared its use in the first-line setting in April this year.

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