AZN - Why AstraZeneca Stock Is Trading Higher Tuesday | Benzinga
Monday, the FDA approved AstraZeneca Plc's (NASDAQ:AZN) Tagrisso (osimertinib) plus chemotherapy for locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
- The approval following an FDA Priority Review was based on the results from the FLAURA2 Phase 3 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.
- Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).
- PFS results from blinded independent central review were consistent with the results by investigator assessment, showing 29.4 months median PFS with ...