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Enhertu, breast cancer and Trastuzumab Deruxtecan
FDA Approves Trastuzumab Deruxtecan for HER2-Low/Ultralow Breast Cancer
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
FDA expands Enhertu approval to include HER2-ultralow breast cancer patients
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In 2022, the drug became the first therapy approved for H
Enhertu Approved for HR+, HER2-Low/Ultralow Metastatic Breast Cancer
Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: NCT04494425 ).
FDA expands Enhertu approval for breast cancer
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of the agent by patients with HER2-low or HER2-utralow metastatic breast cancer whose disease progressed after at least one endocrine therapy.
FDA Approves T-DXd in HR+, HER2-Low/Ultralow Breast Cancer
The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, based on phase 3 DESTINY-Breast06 trial results.
Enhertu gets first okay for HER2-ultralow breast cancer
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster drug as a second-line treatment for patients with HER2-low and HER2-ultralow metastatic breast cancer.
AstraZeneca-Daiichi Sankyo Enhertu gets USFDA approval for HER2-ultralow metastatic breast cancer
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor
FDA Approves Enhertu for HER2-Low and -Ultralow Breast Cancer
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer with disease progression after endocrine therapy.
AstraZeneca Receives FDA Approval for Enhertu Breast Cancer Treatment
AstraZeneca received Food and Drug Administration approval for enhertu, its breast cancer treatment developed in partnership with Japanese company Daiichi Sankyo. The Anglo-Swedish pharmaceutical company said Monday that the treatment's approval was based on results from a Phase III trial,
FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab deruxtecan) for HER2-low metastatic breast cancer in the United States.
Medscape
13d
Trastuzumab Emtansine Ups Long-Term Survival in HER2-Positive Breast Cancer
Patients with HER-2 positive early breast cancer with residual invasive disease after neoadjuvant therapy were randomly ...
Cancer Therapy Advisor
10d
Adjuvant T-DM1 Provides Long-Term Benefits Over Trastuzumab in HER2+ Breast Cancer
Updated results from the KATHERINE trial showed that adjuvant T-DM1 provided a significant improvement in overall survival and no evidence of long-term safety issues.
appliedclinicaltrialsonline
13d
Long-Term KATHERINE Trial Analysis Shows Kadcyla Significantly Improves Survival in HER2-Positive Early Breast Cancer
An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab ...
MedPage Today
12d
Adding Palbociclib to Standard Care Improved PFS in Triple-Positive Breast Cancer
And, in fact, this study showed that the additional palbociclib to this kind of treatment was able to significantly prolong ...
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