The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
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: ...
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...
其中，第一三共的明星产品Enhertu（德曲妥珠单抗）在2024财年前三季度全球销售额为4044亿日元（约26.82亿美元）。经查询，Enhertu在2024年Q1（即2023年财年Q4）销售额为1199亿日元。因此，按自然年计算，Enhertu在2 ...
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...
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