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FDA Grants AstraZeneca's Tagrisso sNDA Priority Review in Unresectable Stage III NSCLC

NEW YORK – The US Food and Drug Administration has granted priority review to AstraZeneca's supplemental new drug application (sNDA) seeking market authorization for Tagrisso (osimertinib) as a treatment for unresectable, stage III EGFR-mutated non-small cell lung cancer after chemoradiotherapy.

AstraZeneca's sNDA includes data from the Phase III LAURA trial, which the company released at the American Society of Clinical Oncology's annual meeting last week and published in the New England Journal of Medicine. In the study, according to blinded independent central review, the EGFR inhibitor Tagrisso reduced the risk of disease progression or death by 84 percent compared to placebo. Researchers noted a trend showing patients on Tagrisso lived longer than on placebo, but overall survival data were not mature at last cutoff for analysis.

"Priority review of Tagrisso in this early-stage curative setting is important for patients who currently have no targeted treatments available," Susan Galbraith, executive VP of oncology R&D at AstraZeneca, said in a statement. "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 monotherapy is already approved in the US and in other countries for advanced EGFR-mutated NSCLC, advanced NSCLC with EGFR T790M resistance mutations, and adjuvant treatment of early-stage EGFR-mutated NSCLC. When combined with chemotherapy, Tagrisso is approved in the US and elsewhere as a frontline option for locally advanced or metastatic EGFR-mutated NSCLC.

"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,” Galbraith added.

The FDA is expected to issue a decision on this sNDA by Q4 2024.