Osimertinib Approved as Adjuvant Therapy for NSCLC with Certain EGFR Mutations

Osimertinib Approved as Adjuvant Therapy for NSCLC with Certain EGFR Mutations

Industry News & Regulatory Approvals
Dec 22, 2020
Regulatory Approval

December 18, 2020—The U.S. Food and Drug Administration (FDA) approved osimertinib as post-resection adjuvant therapy for patients with NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

ADAURA randomly assigned (1:1) 682 patients who had undergone surgery to 80 mg of oral osimertinib daily or to placebo plus standard adjuvant chemotherapy. Although OS data is still a question mark, DFS was very favorable for osimertinib. Median DFS was not reached (38.8, NE) vs 19.6 months (16.6-24.5) for placebo (HR 0.20; 95% CI: 0.15-0.27; p < 0.0001).

New ADAURA data regarding patient-reported outcomes will be presented at the upcoming 2020 IASLC World Conference on Lung Cancer at the end of January 2021. 
 

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