AstraZeneca’s Tagrisso (osimertinib) Receives EU’s Approval for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

May 28, 2021 Auto Bot approval, AstraZeneca, EU, osimertinib, regulatory, Tagrisso 0

Shots:

  • The approval is based on P-III ADAURA trial assessing Tagrisso (80mg, qd, PO) vs PBO in 682 patients with stage IB, II, IIIA EGFRm NSCLC following complete tumor resection and adjuvant CT as indicated for 3 yrs. or until disease recurrence
  • Results: Improvement in DFS in all primary analysis population in Stage II and IIIA EGFRm NSCLC patients and overall trial population, 83% reduction in the risk of disease recurrence or death, and 80% reduction in the overall trial population in patients with Stage IB-IIIA disease
  • Tagrisso is an approved therapy for 1L LA or mEGFRm NSCLC and for LA or mEGFR T790M mutation+ NSCLC in the EU, the US, Japan, China and many other countries

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: New Europe

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