The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
FDA的这一批准是对HER2低表达和超低表达乳腺癌患者未来治疗选择的良好补充,显示了新型靶向疗法在癌症治疗中的巨大潜力。期待在未来的研究中,Enhertu能为更多患者带来生机与希望。 返回搜狐,查看更多 ...
▎药明康德内容团队编辑今日,第一三共(Daiichi Sankyo)与阿斯利康(AstraZeneca)共同宣布,其联合开发的重磅抗体偶联药物(ADC)Enhertu(trastuzumab ...
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...
The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...
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: ...
In February 2024, the government slashed GST (Goods and Services Tax) from three major cancer drugs: Trastuzumab Deruxtecan, ...
The government had earlier cut customs duties on Trastuzumab Deruxtecan, Osimertinib and Durvalumab from 10 per cent to nil ...