FDA grants accelerated approval to Enhertu for HER2-mutant NSCLC and companion diagnostic

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FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. 

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Arjan Gower, a hematologist/oncologist at the UCLA Health Jonsson Comprehensive Cancer Center, received a $950,000 grant from the National Comprehensive Cancer Network and Taiho Oncology Inc. to help launch a multi-institutional clinical trial to test zipalertinib, an investigational drug that targets specific EGFR mutations, including Exon 20 insertions, which are known to drive cancer growth and resist standard treatments. 

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