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 agains