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Osimertinib Receives Priority Review for EGFR-Mutant NSCLC

By: Jocelyn Solis-Moreira, MS
Posted: Thursday, October 29, 2020

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review and accepted a supplemental new drug application for osimertinib. This was for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFR-mutated non–small cell lung cancer (NSCLC) after complete tumor resection with curative intent.

The FDA’s decision to accept the supplemental drug application was based on the findings from the phase III ADAURA clinical trial. The results showed a statistically significant and clinically meaningful improvement in disease-free survival in both the primary analysis population of patients with stage II and IIIA EGFR-mutated NSCLC and in the overall trial population of patients with stage IB to IIIA disease.

Osimertinib is a third-generation, irreversible EGFR tyrosine kinase inhibitor. It previously received approval in the United States, Japan, China, the European Union, and many other countries for first-line treatment of EGFR-mutated advanced NSCLC and EGFR T790M mutation–positive advanced NSCLC.



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