Enhertu approved in the US as first HER2-directed therapy for …
Jan 27, 2025 · With Enhertu, a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.
ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the …
Jan 27, 2025 · With ENHERTU, a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of …
Enhertu showed substantial clinical activity in patients with HER2 ...
Sep 13, 2024 · With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.
ENHERTU® Approved in the U.S. as First HER2 Directed Therapy …
Jan 27, 2025 · Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has ...
ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved ... - AstraZeneca US
Apr 5, 2024 · The safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who received ENHERTU 5.4 mg/kg intravenously once every 3 weeks in DESTINY-Breast04.
FDA approves fam-trastuzumab deruxtecan-nxki for breast cancer
5 days ago · This assay was previously approved to identify patients with HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer for treatment with Enhertu. Full prescribing information for Enhertu will be posted on ...
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
1 day ago · Enhertu® (fam-trastuzumab deruxtecan-nxki) approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies. News release. AstraZeneca and Daiichi Sankyo. January 27, 2025.
FDA Approves AstraZeneca and Daiichi Sankyo’s Enhertu for …
Jan 28, 2025 · The approval makes Enhertu (fam-trastuzumab deruxtecan-nxki) the first HER2-directed therapy in the United States for treating HER2-low or HER2-ultralow metastatic breast cancer.
Enhertu demonstrated statistically significant and clinically ...
Apr 29, 2024 · With Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.
FDA Approves Enhertu for HER2-Ultralow Metastatic Breast Cancer
Jan 30, 2025 · On January 27, the Food and Drug Administration (FDA) expanded the approval of Enhertu (fam-trastuzumab deruxtecan) to cover people with hormone-positive, HER2-ultralow advanced breast cancer following endocrine therapy.