AstraZeneca Reports the US FDA’s sNDA Acceptance of Tagrisso to Treat Lung Cancer


The US FDA has accepted & granted priority review to Tagrisso’s sNDA for treating inoperable, stage III EGFRm NSCLC post chemoradiotherapy (CRT) based on P-III (LAURA) study, with the decision expected in Q4’24
The P-III (LAURA) study assesses Tagrisso (80mg, oral, QD) vs PBO to treat inoperable, stage III EGFRm NSCLC patients (n=216) whose disease did not progress post Pt-based CRT. Patients were switched from PBO upon progression
Study depicted 84% reduction in the disease progression or death risk with 39.1mos. vs 5.6mos. mPFS & a PFS benefit in all prespecified subgroups, OS data was immature; though a favorable trend was seen, its evaluation is underway. Results were highlighted at ASCO 2024 & published in the NEJM

Ref: AstraZeneca | Image: AstraZeneca 

Related News:- AstraZeneca’s Tagrisso Receives the CHMP’s Positive Opinion for Treating EGFR-Mutated advanced Lung Cancer

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