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

April 26, 2021 Auto Bot AstraZeneca, CHMP, EU, osimertinib, Positive Opinion, regulatory, Tagrisso 0

Shots:

  • The recommendation is based 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
  • The study showed improvement in DFS in all primary analysis population of patients with Stage II and IIIA EGFRm NSCLC and in the overall trial population of patients with Stage IB-IIIA disease, 80% reduction in the risk of disease recurrence or death
  • Tagrisso is approved to treat early-stage lung cancer in more than 15 countries, including US and China, and additional global regulatory reviews are ongoing

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

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