FDA grants priority review to AstraZeneca’s Tagrisso for EGFRm NSLC

AstraZeneca’s supplemental New Drug Application or sNDA for TAGRISSO or osimertinib, has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated EGFRm non-small cell lung cancer NSCLC after chemoradiotherapy CRT . If approved, TAGRISSO will be indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 mutations…Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Priority Review of TAGRISSO in this early-stage curative setting is important for patients who currently have no targeted treatments available. We look forward to close collaboration with the FDA on an accelerated path to bring TAGRISSO to patients as a potential new standard of care as quickly as possible. TAGRISSO continues to serve patients as a backbone therapy in EGFR-mutated lung cancer, extending progression-free survival in the LAURA trial by more than three years and reinforcing the importance of testing for EGFR mutations at the time of diagnosis.”