Approval was based on P-III (FLAURA2) study of 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 locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC patients (n=557)
Study depicted 38% PFS & 25.5mos. vs 16.7mos. mPFS as per investigator evaluation; similar PFS with mPFS of 29.4mos. vs 19.9mos. was observed as per BICR. OS data was immature (41% maturity), though a trend was observed, its evaluation is underway
Prespecified exploratory analysis showed 42% reduced CNS disease progression or death risk with 74% vs 54% of patients not having it after 2yrs. follow-up
Ref: Astrazeneca | Image: Astrazeneca
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