AstraZeneca’s Tagrisso Receives Approval from the US FDA for the Treatment of Advanced Lung Cancer
Shots:
- Followed by the Priority Review, the US FDA has approved Tagrisso + CT based on a P-III (FLAURA2) study of the combination vs Tagrisso monotx. as a 1L treatment for locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC
- The results demonstrated a PFS of 38% with the combination and mPFS of 25.5mos. vs 16.7mos. as per investigator assessment. The PFS, as per BICR, was consistent with the investigator assessment and mPFS was 29.4mos. vs 19.9 mos.
- The prespecified exploratory analysis revealed that the combination reduced the risk of CNS disease progression or death by 42% & after 2yrs., 74% of patients on the combination had not experienced CNS disease progression or death vs 54% for Tagrisso alone. OS data is in progress
Ref: AstraZeneca | Image: AstraZeneca
Related News:- AstraZeneca Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Tagrisso to Treat EGFR-Mutated Advanced Lung Cancer
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
