www.fdanews.com/articles/175256-ec-gives-thumbs-up-to-astrazenecas-tagriss
EC Gives Thumbs Up to AstraZeneca’s Tagriss
February 9, 2016
The European Commission blessed AstraZeneca’s Tagrisso for metastatic EGFR T790M mutation-positive non-small cell lung cancer.
The drug was approved in the U.S. in November 2015 for patients who have progressed on or after EGFR TK1 therapy. The FDA approved the drug under the accelerated approval pathway.