AstraZeneca Reports the US FDA’s sNDA Acceptance of Tagrisso to Treat Lung Cancer
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
