AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC
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- Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRT
- Approval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216) with unresectable, EGFRm NSCLC (Stage III), not progressed following definitive Pt-based CRT, across 15 countries; PBO pts could opt for Tagrisso upon disease progression
- 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. Data was published in the NEJM
Ref: Newswire | Image: AstraZeneca | Press Release
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