AstraZeneta's Tagrisso gets FDA priority review

AstraZeneca's EGFR tyrosine kinase inhibitor Tagrisso has been given priority review by the U.S. Food and Drug Administration (FDA) to treat lung cancer with early EGFR mutations.In particular, AstraZenecom is seeking approval from Tagrisso (osimertinib) for complementary treatment for patients with non-small cell lung cancer (NSCLC) with early (Ib, II, IIIA) EGFR mutations after the removal of a complete tumor with healing intent.AstraZenecon's Supplemental New Drug Application (SNDA) for Tagrisso is based on the results of the ADAURA Phase III trial, which showed that the disease-free survival rate (DFS) of the main analytical populations in phase II and IIa EGFR patients had statistically and clinically significant mutations in non-small cell lung cancer.The same results were shown in all trial populations of patients with phase IB/IIIa at key secondary endpoints.Although all non-small cell lung cancer patients can be diagnosed early enough for possible cure surgery, recurrence is still common in early-stage diseases.Nearly half of patients diagnosed with non-small cell lung cancer in phase Ibb and more than three quarters of those diagnosed during stage IIIa relapse within five years.Dave Fredrickson, executive vice president of AstraZeneta's oncology division, said patients with early EGFR mutant lung cancer still have a considerable risk of recurrence after surgery and complementary chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients.He added: "This rapid review highlights tagrisso's unprecedented disease-free survival benefits for patients in an auxiliary environment, and we will continue to work with the FDA to provide patients with this disease-changing treatment as soon as possible." (cyy123.com)original source: