Article
FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.
The oncologist - 5 Aug 2024
Mehta Gautam U, Vellanki Paz J, Ren Yi, Amatya Anup K, Mishra-Kalyani Pallavi S, Pan Lili, Zirkelbach Jeanne F, Pan Yuzhuo, Liu Jiang, Aungst Stephanie L, Miller Claudia P, Shah Mirat, Rahman Nam Atiqur, Theoret Marc, Kluetz Paul, Pazdur Richard, Beaver Julia A, Singh Harpreet
Abstract excerpt
On August 11, 2022, FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd, ENHERTU, Daiichi Sankyo) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The approval was based on...
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