Article
FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
Clinical cancer research : an official journal of the American Association for Cancer Research - 1 Feb 2023
Duke Elizabeth S, Stapleford Liza, Drezner Nicole, Amatya Anup K, Mishra-Kalyani Pallavi S, Shen Yuan-Li, Maxfield Kimberly, Zirkelbach Jeanne Fourie, Bi Youwei, Liu Jiang, Zhang Xinyuan, Wang Hezhen, Yang Yuching, Zheng Nan, Reece Kelie, Wearne Emily, Glen Jacqueline J, Ojofeitimi Idara, Scepura Barbara, Nair Abhilasha, Bikkavilli Rama Kamesh, Ghosh Soma, Philip Reena, Pazdur Richard, Beaver Julia A, Singh Harpreet, Donoghue Martha
Abstract excerpt
On September 15, 2021, the FDA granted accelerated approval to mobocertinib (Exkivity, Takeda Pharmaceuticals USA, Inc.) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The approval was based on data from Study...
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