AstraZeneca’s Tagrisso (Osimertinib) Secures the EC’s Approval to Treat Unresectable EGFR-Mutated Lung Cancer
Shots:
- Following the CHMP’s positive opinion, the EC has approved Tagrisso to treat locally advanced, unresectable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, based on P-III (LAURA) study. Further filings are under review in China, Japan & other regions
- The P-III study assessed Tagrisso vs PBO among adults (n=216) with unresectable, EGFRm NSCLC (Stage III), not progressed following definitive Pt‑based CRT, across 15 regions
- Study depicted a reduction in the disease progression or death risk by 84%, with mPFS of 39.1 vs 5.6mos.; OS (2EP) evaluation continues. Safety profile was consistent & tolerable without any new signals; data was published in the NEJM
Ref: AstraZeneca | Image: AstraZeneca
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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.