EU positive on Tagrisso



AstraZeneca said European regulators had adopted a positive opinion of its drug Tagrisso, recommending a change to the terms of its marketing authorisation to include treatment for certain lung cancer conditions. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its recommendation on results from a Phase III FLAURA trial, presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine. ‘This positive recommendation acknowledges Tagrisso’s potential as a new first-line standard of care for patients with EGFR-mutated NSCLC in Europe,’ chief medical officer Sean Bohen said. ‘It reflects the strength of the FLAURA data that show Tagrisso delivered a statistically-significant and clinically-meaningful improvement in progression-free survival over the EGFR-TKI comparator arm across all pre-specified patient subgroups, including those with or without central nervous system metastases.’ At 1:04pm: (LON:AZN) AstraZeneca PLC share price was +77.5p at 5069.5p Story provided by