AstraZeneca's Tagrisso gains FDA approval for stage III NSCLC [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
Last astrazeneca plc - american depositary shares earnings: 2/5 04:00 pm
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Source: Yahoo! Finance
The FDA's decision was based on the results from the LAURA Phase III trial. Tagrisso demonstrated an 84% reduction in the risk of disease progression or death when compared to a placebo. This was determined through an assessment by a blind independent central review (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p While the overall survival (OS) results are still considered immature at this stage of analysis, the study continues to evaluate OS as a secondary endpoint. AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “The approval of Tagrissofor patients with stage III, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before. “The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung
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AZN
Sec Filings
- 9/26/24 - Form 6-K
- 9/23/24 - Form 6-K
- 9/23/24 - Form 6-K
- AZN's page on the SEC website