The US regulator has approved the drug after a priority review on the strength of data from the FLAURA 2 study showing that the combination of EGFR inhibitor Tagrisso (osimertinib) and chemo cut the risk of disease progression or death by 38% compared to Tagrisso alone in treatment-naïve EGFR-positive NSCLC patients.
The study, which was published in the New England Journal of Medicine last November, revealed that progression-free survival was extended by around nine months with the combination versus Tagrisso alone.
