FDA accepts Tagrisso submission for 1st-line nsclc
18 December 2017 07:00 GMT US FDA ACCEPTS REGULATORY SUBMISSION FOR TAGRISSO IN 1ST-LINE EGFR-MUTATED NON-SMALL CELL LUNG CANCER Acceptance follows FDA Breakthrough Therapy Designation Tagrisso granted Priority Review AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line