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

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  • The CHMP’s positive opinion of Tagrisso + pemetrexed & Pt-based CT as a 1L treatment of locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC with exon 19 deletions or exon 21 (L858R) mutations was based on P-III (FLAURA2) study 
  • The P-III (FLAURA2) study assessed Tagrisso (80mg, oral, QD) + CT [pemetrexed (500mg/m^2) + cisplatin (75mg/m^2) or carboplatin (AUC5), Q3W] followed by Tagrisso with pemetrexed maintenance (Q3W) in the above indication among 557 patients 
  • The study depicted 38% reduced disease progression or death risk & 25.5mos. vs 16.7mos. mPFS with immature OS data (41% maturity); though a trend was seen in OS benefit, its evaluation is underway. Data was published in the NEJM 

Ref:AstraZeneca  | Image:AstraZeneca | Press Release

Related News:- AstraZeneca’s Truqap Plus Faslodex Receives the CHMP’s Positive Opinion for Treating Breast Cancer 

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