AstraZeneca's Tagrisso (osimertinib) Receives the NMPA's Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer
Shots:
- The approval is based on results from the P-III ADAURA trial assessing Tagrisso (80mg- qd) vs PBO in 682 patients with stage IB- II- IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated for three years or until disease recurrence
- Results: Improvement in DFS in all population- 83% reduction in the risk of disease recurrence or death in patients with stage II and IIIA disease- 80% reduction in overall trial population in patients with stage IB-IIIA disease- safety & tolerability were consistent with previous trials in the metastatic setting
- Tagrisso marks the third approval in China following previous approvals in 2L T790M and 1L EGFRm NSCLC
Ref: AstraZeneca | Image: New Europe
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