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AstraZeneca's Tagrisso (osimertinib) Receives the US FDA's BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

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AstraZeneca's Tagrisso (osimertinib) Receives the US FDA's BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

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  • The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB- II- IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated across 20 centers and 200+ countries including the US- EU- South America- Asia- and the Middle East
  • The study resulted in improvement in DFS- reduction in risk of disease recurrence- or death by 79% in the adjuvant treatment of Stage IB-IIIA EGFRm NSCLC patients- also presented at ASCO 2020. Additionally- the trial will continue to assess OS
  • Tagrisso (osimertinib) is third-generation- irreversible EGFR-TKI once-daily oral tablets approved 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC in the US- Japan- China- the EU

Ref: AstraZeneca | Image: AstraZenca

 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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