Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...

As seen in the DESTINY-Breast06 trial, a pproximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.1 These patients may now be ...

1月27日，第一三共与阿斯利康(AZN.US)宣布Enhertu（德曲妥珠单抗）的补充生物制品许可申请（sBLA）获FDA批准，用于单药治疗在转移性环境中接受过至少一种内分泌治疗的不可切除或转移性HER2低表达（IHC 1+或IHC 2+/ISH-）或HER2超低表达（IHC 0）乳腺癌成人患者。

用于单药治疗在转移性环境中接受过至少一种内分泌治疗的不可切除或转移性HER2低表达（IHC 1+或IHC 2+/ISH-）或HER2超低表达（IHC 0）乳腺癌成人患者。

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 (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 progressed on 1 or more endocrine therapies in the ...

human epidermal growth factor receptor 2 (HER2)-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization [ISH]-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer ...

Assessment of HER2 is recommended in every newly diagnosed case of breast cancer. Immunohistochemistry ... to establish the methods and criteria of interpretation to improve the selection of ...

Komen advocacy organization. HER2-ultralow is defined as immunohistochemistry (IHC) 0 with membrane staining. T-DXd, an antibody-drug conjugate now approved for multiple tumor types, gained ...

The approval expands use of the antibody-drug conjugate among patients with very low HER2 expression based on immunohistochemistry (IHC) testing. HER2-low is defined as an IHC result of 1+ or 2+ with ...

The FDA has granted approval to fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) for treating adult patients with unresectable or metastatic, hormone receptor–positive, HER2-low (immunohistochemistry ...