AstraZeneca Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Tagrisso to Treat EGFR-Mutated Advanced Lung Cancer
Shots:
- The US FDA has accepted the sNDA & granted Priority Review for Tagrisso + CT to treat adult patients with LA or metastatic EGFRm NSCLC. The US FDA’s decision is expected in Q1’24.
- The sNDA was based on the P-III trial (FLAURA2) of Tagrisso (80mg, qd) + CT vs Tagrisso alone in 557 patients in 150+ centers across 20+ countries, incl. in the US, EU, South America & Asia, showed a 38% reduction in risk of disease progression or death & extended m-PFS was 8.8mos. by investigator assessment
- PFS results were consistent & showed extended m-PFS by 9.5mos., PFS benefit was seen across all prespecified subgroups, 53% reduction in risk of disease progression or death with extending m-PFS by 11.1mos. The OS data were immature & showed a favorable trend for Tagrisso + CT
Ref: Business Wire | Image: AstraZeneca
Related News:- AstraZeneca Reports P-III (T2NOW) Trial Results of Forxiga (dapagliflozin) for Type 2 Diabetes
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
