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Osimertinib Given Breakthrough Therapy Designation for EGFR-Mutated Lung Cancer

By: Jocelyn Solis-Moreira, MS
Posted: Tuesday, August 4, 2020

On July 30, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to osimertinib in the adjuvant treatment of patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer (NSCLC) after complete tumor resection with curative intent. Currently, osimertinib is approved for first-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC and for treatment of locally advanced or metastatic EGFR T790M mutation–positive NSCLC in the United States, Japan, China, the European Union, and other countries around the world. Osimertinib is a third-generation, irreversible EGFR tyrosine kinase inhibitor.

The designation was based on data from the double-blind, global, phase III ADAURA trial presented at the ASCO20 Virtual Scientific Program. The study enrolled 682 patients with stage IB, II, or IIIA EGFR-mutant NSCLC following complete tumor resection and adjuvant chemotherapy. Patients received 80-mg oral tablets of osimertinib once daily for 3 years or until disease recurrence. Results showed a statistically significant and clinically meaningful improvement in disease-free survival in patients with stage IB to IIIA EGFR-mutant NSCLC; the risk of disease recurrence or death decreased by 79% (hazard ratio = 0.21; 95% confidence interval = 0.16–0.28; P = .0001). Future research will evaluate osimertinib’s effect on overall survival.



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