New FDA approval for Astra Zeneca’s Tagrisso
UK pharma major AstraZeneca’s (LSE: AZN) shares were up 2.7% at 10,094 pence Friday, after it revealed that its Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the USA for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The approval following a priority review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. Tagrisso, with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001).
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