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FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
… granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with … breast cancer since the introduction of Herceptin (trastuzumab) in 1998. The approval of Enhertu represents the …
La FDA aprueba la primera terapia dirigida para el cáncer de mama bajo en HER2
… UU. (FDA, por sus siglas en inglés) aprobó Enhertu (fam-trastuzumab-deruxtecan-nxki), una infusión intravenosa para el … … Office of the Commissioner … La FDA aprobó Enhertu (fam-trastuzumab-deruxtecan-nxki), una infusión intravenosa para …
Oncology Regulatory Review
… solid tumors. Other notable approvals included: Fam-trastuzumab deruxtecan-nxki, for unresectable or metastatic HER2-low … 1, 3 (alpelisib) PROS 81 Y Y 5/4/2022 Enhertu 2 (fam-trastuzumab) unresectable or met HER2+ BC 62 Y Y 5/27/2022 …
FDA Roundup: April 9, 2024
… On Friday, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult …
Oncology Regulatory Review
… Name(s) Indication AAid/RTOR 1. 1/15/2021 Enhertu 5 (fam-trastuzumab deruxtecan-nxki) GEJ Y/N 2. 1/15/2021 Darzalex Faspro 1 …
OCE Publications
… US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor … PMCID: PMC10272032. FDA Approval Summary: Tucatinib with trastuzumab for advanced unresectable or metastatic, …