Article
FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non-Small Cell Lung Cancer, a Collaborative Project Orbis Review.
Clinical cancer research : an official journal of the American Association for Cancer Research - 15 Dec 2021
Koch Abigail L, Vellanki Paz J, Drezner Nicole, Li Xiaoxue, Mishra-Kalyani Pallavi S, Shen Yuan Li, Xia Huiming, Li Yangbing, Liu Jiang, Zirkelbach Jeanne Fourie, Palazov Elitza, Gamarian Aleksandr, Choo Qiuyi, Girčys Arūnas, Rohr Ulrich-Peter, Fesenko Nataliya, Spillman Dianne, Pazdur Richard, Beaver Julia A, Singh Harpreet
Abstract excerpt
On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. The approval was based on the ADAURA study, in which 682 patients with NSCLC were randomized to receive osimertinib (n = 339) or placebo (n = 343). Disease-free survival (DFS) in the...
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