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

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AstraZeneca

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 

Related News:- AstraZeneca Reports the P-III (FLAURA2) Study Results Evaluating Tagrisso Plus Chemotherapy to Treat Advanced Lung Cancer

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Disha Nankani

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.

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