AstraZeneca’s Tagrisso (osimertinib) Receives the NMPA’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer
AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021
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
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