AstraZeneca’s lung cancer treatment has been approved by the EU for first line use in patients
AZ’s Tagrisso has been given a go-ahead in Europe for first-line use to treat EGFR-mutated non-small cell lung cancer (NSCLC), offering a new line of attack at this stage of the disease.
The decision was based on clinical data from the Phase III FLAURA trial, showing that progression free survival in patients taking Tagrisso (osimertinib) was approximately 19 months when compared to just over 10 months for those receiving the standard of care, while the objective response rate was 80% versus 76%, respectively. It has also been noted that the decision will significantly expand the drug’s reach within Europe.
Further analysis of FLAURA results, which was 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 various countries as a second-line treatment for patients with EGFR T790M mutation-positive advanced NSCLC.
The US FDA also cleared its use in the first-line setting in April 2018.