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AstraZeneca's EGFR tyrosine kinase inhibitor Tagrisso (osimertinib) has been given priority review by the U.S. Food and Drug Administration (FDA) for complementary treatment in patients with early (Ib, II, IIIA) non-small cell lung cancer (NSCLC) mutations after surgical removal.
AZ's Application for Complementary New Drugs (SNDA) for Tagrisso is based on the results of the ADAURA Phase III clinical trial, which showed statistically and clinically significant improvements in disease-free survival (DFS) in patients with EGFR mutations after Tagrisso's treatment.
that although 30% of NSCLC patients can have surgical removal due to an earlier diagnosis, recurrence is still common.
half and more than three-quarters of patients with Phase II and Phase II NSCLC had cancer recurrence within five years, respectively. Dave Fredrickson, executive vice president of
's Oncology division, said: "EGFR mutant lung cancer patients still have a considerable risk of recurrence after surgery and complementary chemotherapy, and new targeted treatments are critical to improving outcomes for these patients.
"